Nitrosamine Impurities Affecting Drug-Drug Interaction Studies – Learn More

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Drug Development for Women’s & Men’s Health

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Clinical and Bioanalytical Biologics Experience & Expertise

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Supporting Inhaled Drug Development

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Pulmonary Sampling Techniques & Sample Analysis

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Immune Challenge Models For Drug Development

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A European Bioanalysis Forum Recommendation for Requiring a Context-of-Use Statement for Successful Development and Validation of Biomarker Assays

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ASCPT 2024 Abstract – MRX-5LBT Photosafety

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Surfing the T Wave: A Primer on ECG T Wave Morphologies Encountered in Clinical Trials and Impact on the QT Interval and Patient Safety

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Drug-Drug Interaction Studies Recommended for Novel GLP-1 Receptor Agonists

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Peptide Drugs: Clinical & Bioanalytical Drug Development

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Clinical and Bioanalytical Oligonucleotide Experience and Expertise

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Clinical and Bioanalytical Support for Monoclonal Antibody Drugs

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Leaders in Early Metabolic Disease Studies

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Automated Singlicate Biomarker Assay: Enhancing Assay Performance by Surrogate Matrix Optimization

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The Rollercoaster Between Free Drug Tolerance and Target Interference in the Development of an Antidrug Antibody Assay

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Food Effect, Gastric Emptying, ARA’s, GLP-1 agonists

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AAV8 Shedding Assay to Support Gene Therapy Clinical Trials

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Development of 24-Hour Rhythms in Cortisol Secretion Across Infancy

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Patient-Screening in AAV Gene Therapy: Only High Anti-AAV Titers Impact Transduction and Efficacy

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Drug Absorption & Impact of Food, Gastric pH, Gastric Emptying and GLP-1 Agonists

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Case Study: Bioanalytical Support of Oncology Studies

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Celerion: Your Partner for High-Quality PBMC Processing & Clinical Site Training

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Leaders in Biosimilars

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Randomized Trial of Pharmacokinetic and Pharmacodynamic Effects of 13.2 mg Intranasal Epinephrine Treatment in Congestion

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Innovative Approaches to Optimize Clinical Transporter Drug–Drug Interaction Studies

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Comprehensive Cardiovascular Safety and ECG Core Laboratory Services

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Predictive Value of Nonclinical ADME Findings for Clinical Excretion Routes

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Phenytoin: A Safe and Potent Alternative to Rifampin as CYP3A Inducer in Drug-Drug-Interaction Studies

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A 13.2 mg Epinephrine Intranasal Spray Demonstrates Comparable Pharmacokinetics, Pharmacodynamics, and Safety to a 0.3 mg Epinephrine Autoinjector

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The Rollercoaster Between Free Drug Tolerance and Target Interference in the Development of an Anti-Drug Antibody Assay

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Leverage Our Regulatory Experts for Pre-IND and IND Support

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Developing an Ultrasensitive PK Assay Using SIMOA: Step-by-Step to the Target

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Low Cut Points: Where Has Our Biological Variability Gone?

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Critical Reagent Characterization of Biotinylated Antibody Conjugates in a Flow Cytometry-Based Receptor Occupancy Assay

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Optimizing Cell Viability in Cell Therapy: A Comparative Study of Whole Blood Sample Stabilization Techniques

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Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations

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AAV8 Shedding Assay to Support Gene Therapy Clinical Trials

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No Photosafety or Photoallergy Effect with MRX-5LBT (10%) Lidocaine Patch Administration

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What to Expect from a Phenytoin Drug-Drug Interaction Study: Adverse Event Profiling and Safety Assessment

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Pharmacokinetic and Pharmacodynamic Relationships of Intranasally Administered and Intramuscularly Injected Epinephrine

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Expert Drug-Drug Interaction Study Design and Conduct

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Food Effect Study Best Practices

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Leverage Our Renal/Hepatic PK Study Experience & Expertise

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Leaders in Bioequivalence and Bioavailability Studies

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Preexisting Antibody Assays for Gene Therapy: Considerations on Patient Selection Cutoffs and Companion Diagnostic Requirements

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Unraveling CYP3A Gut vs Liver Drug Metabolism and P-glycoprotein Activity

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Celerion: Leading Your Research into the Future with Premium Flow Cytometry Services

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Celerion: Accelerating Therapeutic Futures with Molecular Biology Services

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Drug Labeling Studies in Clinical Pharmacology: Recent FDA/EMA Updates

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Flushing Out Translational Excretion Data: How Well Do Nonclinical ADME Results Predict Clinical Findings?

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Continuing the Conversation: Audience Questions from ASCPT Journal Family Webinar “Alternatives for Rifampin as a CYP3A Inducer in DDI Studies in View of N-Nitrosamine Impurity Issues.”

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Alternatives for Rifampin as a CYP3A Inducer in DDI Studies in View of N-Nitrosamine Impurity Issues

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Impact of the FDA’s Revised Draft Guidance on Renal Impairment PK Studies—Trends, Challenges and Solutions

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Women’s Health: Maximizing Study Design of Combined Oral Contraceptives Drug Interaction Studies

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Perpetrator or Victim: Evaluating Therapeutic Proteins in Drug-Drug Interaction Studies

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Phil Bach, Executive Vice President, Celerion goes one-on-one with Clinical Leader

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AAV Vector Shedding Assay— Best Practices in Clinical Gene Therapy Method Development

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Onsite Pharmacy Compounding for Your Phase 1 Clinical Study Webinar

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Global Cell and Gene Therapy Services Overview

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The Impact of N-nitrosamine Impurities on Clinical Drug Development: Drug-Drug Interaction Studies

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The Impact of N-nitrosamine Impurities on Clinical Drug Development

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Refining Transporter DDI Studies with Endogenous Biomarkers

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Prevalence of Baseline Cardiac Arrhythmias in Participants with Overweight or Obesity in Phase 1 Clinical Trials: Analysis of 24-Hour Holter Electrocardiogram Recordings

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Celerion’s Zurich Bioanalytical Lab Tour

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The Pioneering Tech Speeding Up Drug Development

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Nitrosamine Impurities in Rifampin – What Does it Mean for Your Drug-Drug Interaction (DDI) Study

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Simultaneous Quantitation of δ9-Tetrahydrocannabinol, Cannabidiol and Their Metabolites in Human Plasma Coupled to a Highly Sensitive Method for Quantitation of Trace Amount of δ9-Tetrahydrocannabinol

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Assessing Trends in HbA1c Over 4 Years in Phoenix Metropolitan Area Ethnic Populations

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A Dramatic Increase in Free Drug Tolerance Using PandA Compared to Standard Acid Dissociation

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qPCR vs. ELISpot: Which Assay is Better to Assess Antigen-Specific IFN-γ Secretion in PBMCs?

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Overcoming Rifampin Impurity Challenges for DDI Studies: Phenytoin as an Alternative

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Product Labeling Studies

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Celerion’s Lincoln Bioanalytical Lab Tour

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Lessons Learned From 50+ Years of First-in-Human Clinical Experience

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2022 DIA – SARS-CoV-2 Viral Levels and Antibody Response in Mildly Symptomatic and Asymptomatic Participants

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2018 ADA – Evaluating the Distribution of Diabetes and Prediabetes in Arizona’s Maricopa County

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2018 Land O’Lakes – Development of PK and Anti-Drug Antibody Assay with High Drug Tolerance for Bevacizumab (Avastin®) and its Biosimilars

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2018 Land O’Lakes – Approaches to Improve Sensitivity and Drug Tolerance by Reducing Target Interference During Development of an Anti-Drug Antibody Assay

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2021 Oxford Biomarkers – Biomarkers: Biology vs Bioanalysis

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2022 EUFEPS – Overcoming Rifampin Impurity Challenges for DDI Studies: Phenytoin as an Alternative

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2022 EBF YSS – Tackling Sample Loss and Lot-to-Lot Variability During Protein Labeling

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Rifampin Drug-Drug-Interaction Studies; Reflections on The Nitrosamine Impurities Issue

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SARS-CoV-2 PCR Assay Validation – Nasopharyngeal vs Saliva Sample Collection

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SARS-CoV-2 Viral RNA Load is Associated with the Number of COVID-19 Symptoms Experienced in Mildly Symptomatic Adults: An Observational Study

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Onsite Pharmacy Compounding for Your Phase 1 Clinical Study

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Partnering with Large Pharmaceutical Companies

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Partnering with Biotechnology Companies

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IND Support for Asian Biotech

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EU Biotech Needs First-in-Human FDA Support

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High Throughput Bioanalytical Analysis

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Making Virtual Trials a Reality

Back to Basics: pH-Dependent Drug Interactions with Acid Reducing Agents

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Clinical and Bioanalytical Aspects of Immune Monitoring via ELISpot

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2021 EBF – Full automation of CD34+ cells enumeration by flow cytometry: from low-throughput single tubes to high-throughput 96-well plates

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2021 AAPS – Critical Components of Elispot Validation and Sample Analysis in a GLP environment

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2021 EBF – Challenging Matrix: How to extract a peptide-Analogue from Human breast Milk for LC-MS/MS analysis?

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2021 EBF – How to deal with the Challenges of Nab assays: Case Studies evaluated

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2021 EBF – How sample acidification can save your PK Assay

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Global Clinical Development: Rapid Advancement into Phase 2

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Bioanalytical Sciences

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PharmSci 2021 – Development and Validation of Nasopharyngeal and Saliva Ultrasensitive Quantitative SARS-CoV2 PCR Assays for a COVID-19 Observational Study

PharmSci 2021 – Critical Components of Elispot Validation and Sample Analysis in a GLP environment

PharmSci 2021 – Total Nitrate Nitrite

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2021 ACCP – Application of Fibroscan for hepatic safety monitoring in early clinical studies

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A COVID-19 Observational Study- Evaluation of Changes in Viral Load over Time in Otherwise Healthy Asymptomatic Participants with Detectable Levels of SARS-CoV-2 Virus

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Bioanalytical Assay List

Biomarker Excellence

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COVID-19 and Re-Commencement of Early Phase Clinical Trials in Respiratory Medicine

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Update on ICH E14-S7B Cardiac Safety Regulations

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Women’s Health: Maximizing Study Design of Combined Oral Contraceptives Drug Interaction Studies

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Optimizing Early Clinical Trials in Special Populations

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Perpetrator or Victim: Evaluating Therapeutic Proteins in Drug-Drug Interaction Studies

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Human Trials For Lyme Disease Shot Kickoff In Nebraska

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Size Matters: How Revised FDA Renal Impairment PK Study Guidance Will Impact Future Studies

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Speed of Science

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Bioanalytical Support of Biosimilars Expect the Unexpected

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CIO Look: Translating Scientific Ideas into Potential Medicines

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Non-Invasive Measurement of Lower Respiratory Cytokine Biomarkers with PEXA and Ultrasensitive Immunoassays

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Optimizing PBMC & Flow Cytometry Results: Sampling, Prep & Analysis in a Combined Clinic and Lab Environment

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Rapid SARS-CoV-2 Assay Development Technologies: Recombinant Antibodies, In-Vitro Assays, and Biomarkers

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Leveraging Pathophysiology and Context-of-Use to Identify MASH Clinical Trial Biomarkers

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The Analytical and Clinical Validation of Caspase-Cleaved Keratin 18 Fragments, M30 as a Promising NAFLD Biomarker

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Peptide Drug Development: Bioanalysis of Peptides

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Peptide Drug Development: Clinical Pharmacological Considerations

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Biomarker Assay Development and Validation: Failing Your Way to Success

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Challenges and Solutions for Sputum Biomarkers To Support Cystic Fibrosis Clinical Studies

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Optimizing Renal and Hepatic Impairment Clinical Trial Designs

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The Rising Bar: How US Regulatory Requirements for Pharmacy Compounding Impact Early Clinical Pharmacology Studies

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Introducing Laboratory Automation into a Regulated Environment: From Proof of Principle to High End Solutions

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Quantification of 11 Dehydro Thromboxane b2 in Human Urine by LC-MS/MS Selective and Sensitive

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Development of a Novel Enzyme-free Approach to Determine N’-Nitrosonornicotine (NNN) in Human Urine

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Coping with Pre-existing Antibodies in Innovative Cancer Immunotherapy

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Challenging the Impossible: A Highly Drug Tolerant and Sensitive Neutralizing Antibody Assay Towards a Monoclonal Antibody Therapy in Neurodegenerative Disease

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Revised Renal Impairment PK Study Guidance: Key Takeaways

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Seeing Through the MIST: Metabolite Identification and Profiling Strategies

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Association of Testosterone Levels and Steroid 5-Alpha-Reductase 2 Polymorphisms with Opioid Craving

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Celerion to Present at Upcoming Veeva Summit

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Ten Years of Scientific Insight

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Biosimilar Development: Lessons Learned From Early Clinical Studies

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Celerion Achieves Reaccreditation for Its Protection of Participants in Clinical Research.

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Faster Forward with Accelerated First in Human to Proof Of Concept Early Phase Vaccine Trials

QT Assessment in Early Drug Development: The Long and the Short of It

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Evaluating Cardiac Risk: Exposure Response Analysis in Early Clinical Drug Development

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Early Stage (Respiratory) Trials In the Time of COVID-19

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Analytical Challenges Developing an Ultrasensitive Simoa Immunoassay for

LaunchBio recording and slides: Everything is Fine; Clinical Drug Development During a Pandemic – Aernout van Haarst

Covid-19Recorded WebEx

Nuventra recording: Drug Development During COVID-19 Panel Discussion Part 2 – Phil Bach

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Development of an Antibody Dependent Enhancement(ADE) Assay to Support SARS-CoV2 Vaccine Development

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Developing an Ultrasensitive Simoa Immunoassay for IL-1β as a Biomarker for MASH

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Nuventra Recording: Drug Development During COVID-19 Panel Discussion – Fred Pritchard

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Analytical Challenges Developing an Ultrasensitive Simoa Immunoassay for IL-1B as a Biomarker for MASH

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Bioanalytical Assays to Support COVID-19 Drug Development

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Introducing Automation to a Regulated Laboratory – An Experience Report

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Challenges in Biosimilar Bioanalytical Assays and Sample Processing

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Everything is Fine: Clinical Drug Development During a Pandemic

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Bioanalytical and biomarker assay development for COVID-19 Therapeutics and Vaccines

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Designed for Success: Early Phase Study Design For Biotech

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ADME 101: Lessons on Running a Successful Clinical Mass Balance Trial

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The ABC’s of Vaccine Development

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Celerion Vaccine Development

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Developing Vaccines for the Coronavirus Disease (COVID-19) Outbreak

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The Future of Pharmacy

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Early Development Capabilities for Vaccine Studies

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Bioanalytical Capabilities for Vaccines

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Client Communication 3-16-2020

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Respiratory and Nasal Studies Challenges

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Celerion Celebrates the Passion of Our Employees and a Commitment to Excellence Over the Last Ten Years.

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Adaptive, Innovative Designs to Accelerate Development from FIH to First-in-patient

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Short Communication: Interaction of Nerve Growth Factor (NGF) and Vascular Endothelial Growth Factor (VEGF) in Healthy Individuals

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The ABC’s of MASH

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Why Celerion for NAFLD/MASH Development?

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Challenges and Solutions for NAFLD/MASH Phase I-IIa Clinical Studies

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Quantitation of Insulin Analogue Glargine and its two Metabolites M1 and M2 in Human Plasma Using a Hybrid IP LC MSMS Approach

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Development of a New LC MS/MS Assay to Determine 7α hydroxy 4 cholesten 3 one C4, a Bile Acid Synthesis Biomarker in Human Serum

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Cutting-Edge Method for the Detection of Anti-Drug Antibodies with Record Free Drug Tolerance: Be safe with PandA

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Comparative Study of Cell-Based and Competitive Ligand-Binding Assays for the Detection of Neutralizing Antibodies Against a Therapeutic Peptide Hormone

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Biomarkers Challenges: SiMoA Makes the Tiny but Significant Difference

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Assay Validation and Clinical Performance of Chronic Inflammatory and Chemokine Biomarkers of MASH Fibrosis

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Challenges in Biomarker Analysis: SiMoA (Single Molecule Array) Makes The Tiny but Significant Difference

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ACCP 2019 – Optimizing I/E Criteria for Early MASH Clinical Studies with FibroScan®

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Collaborating to Bring New Biomarkers to Tackle COPD

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Development and Qualification of a Sensitive and High Throughput Cell Based Neutralizing Antibody Assay for Bevacizumab

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A Fully Automated Workstation for SPE Applications

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Review of Drug Development Guidance to Treat Chronic Obstructive Pulmonary Disease: US and EU Perspectives

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Preventative Vaccines for Insect-Borne Diseases

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Assay Validation and Clinical Performance of Chronic Inflammatory and Chemokine Biomarkers of MASH Fibrosis

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ICH M10 Guidelines Impact on Bioanalytical Method Development and Validation

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A Sensitive and Robust Method for the Determination of Glucagon in Human Plasma by UHPLC-MS/MS

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Alphalisa – A New, Simple, Highly Sensitive Technology for HTP Quantification of Small Human Proteins in Matrix

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Early Phase Clinic – Belfast

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Early Phase Clinic – Phoenix

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Early Phase Clinic – Lincoln

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Celerion ADME and Radiolabel Capabilties

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Celerion_FibroScan-Advantage-in-Early-MASH-Clinical-Studies_WP_011419-1

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Aegyris The Simple and Efficient Solution for the Validation of Immunogenicity Assays to Support Vaccine Clinical Trials

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Leveraging Non-Invasive Approaches in NAFLD/MASH Clinical Research

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Biomarker and Bioanalytical Assays for Immuno-oncology Drug Development

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Biomarker Validation and Flow Cytometry: An Interview with Rafiq Islam

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Recommendations for Classification of Commercial LBA Kits for Biomarkers in Drug Development from the GCC for Bioanalysis

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Immunogenicity and Safety of Vaccines for the ICU

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Challenges and Solutions of ADC Bioanalysis -A Case Study

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Challenges in FGF-21 Metabolic Biomarker Assay Development

Scientific Poster

Physicochemical Interactions Between Analyte and Laboratory Material: Impact on Accuracy

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A Novel Trap-and-Elute LC-MS/MS Method to Quantify Acyl Ghrelin and Des-Acyl Ghrelin in Human Plasma

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Immunophenotyping of CD8+ Tscm cells

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Qualification of an IFN- g Elispot Assay in the Bioanalytical Laboratory

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Evaluation of an ELISA Method Using Novel Amplification Reagent and Its Comparison with Traditional Colorimetric ELISA Assay for the Measurement of Aflibercept in Biological Matrices

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Development and Validation of an ELISA Method for the Determination of Anti-Polyethylene Glycol (PEG) Antibodies in Human Serum

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Qualification of an LC-MSMS Method for the Simultaneous Determination of Desipramin eand 2-Hydroxydesipramine in Human Plasma

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Exploratory Studies in Cystic Fibrosis

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Interferon-Gamma Elispot Assay: Unique Challenges of Validating Immune Monitoring Assays in a Regulated Environment

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Single and Multiple Dose Pharmacokinetics of YPL-001, a Novel Botanical Drug Product in Development for the Treatment of Respiratory Inflammatory Diseases

Scientific Poster

Alphalisa – A New, Simple, Highly Sensitive Technology for HTP Quantification of Small Human Proteins in Matrix

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Neutralizing Antibody Assays: To Be Cell Based or Ligand Binding, That’s the Real Question

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Immunogenicity Assessment of Pro- and Peptide Hormone Release in Engineered Tissues

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Immunogenicity Assessment By RIA, Not Just A Method Past Its Prime

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Celerion’s Highly Automated ECG Core Lab Enables Clients’ Faster Access to High-Quality Data at a Lower Cost

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Creative Solutions for Designing and Conducting Cardiovascular Safety Studies

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Scientific Breakthroughs and Their Impact on Drug Development Efforts in Vaccines

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Lipo-polysaccharide (LPS) Challenge in Healthy Study Participants

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Adaptation of Commercial Biomarker Kits and Proposal for ‘Drug Development Kits’ to Support Bioanalysis: Call for Action

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Semen Clinical Studies

Case Study

Mass Balance Study

Case Study

Assessment of the Abuse Liability of Three Menthol Electronic Cigarettes Relative to Combustible Cigarettes and Nicotine Gum

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Responding to an Unexpectedly High Drop Rate

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Standardizing Database Structure for Programs

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Partnering with Biotechnology Companies

Case Study

Partnering with Large Pharmaceutical Companies

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Generic Study Protocol Design and Development

Case Study

Difficult to Recruit Population

Case Study

Measurement of Cardiovascular and Pulmonary Function Endpoints and Other Physiological Effects Following Partial or Complete Substitution of Cigarettes with Electronic Cigarettes in Adult Smokers

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Rapid Proof-of-Concept for Novel Drug Treatment

Case Study

Proof-of-Concept Efficacy Clinical Study

Case Study

IND for Novel First-in-Class Small Molecule Drugs

Case Study

IND Support for Asian Biotech

Case Study

EU Biotech Needs First-in-Human FDA Support

Case Study

Customized Program Plan for Opening IND Study

Case Study

Partnering with Pharmaceutical Companies

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High Throughput Bioanalytical Analysis

Case Study

Improve Desmopressin Analysis of Samples

Case Study

Our Clinics

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Your Unique Path to Vaccine Development

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Cancer Epidemiology, Biomarkers & Prevention

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Biomarker Qualification and Validation Challenges: The Insulin Case Study

Case Study

Use of Alkaline Mobile Phase to Achieve Good Peak Shape in The Rapid Lc-Ms/Ms Analysis of Lisinopril in Human Plasma

Scientific Poster

2018 WRIB – Total and Free VEGF Assays with High Drug Tolerance for the Anti-VEGF Inhibitors Avastin (Bevacizumab), Lucentis (Ranibizumab), and Eylea (Aflibercept)

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Cystatin C Is a More Reliable Biomarker for Determining eGFR to Support Drug Development Studies

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A Randomized, Double-Blind, Placebo Controlled, Multicenter Phase 2a Study to Assess Safety, Daily Respiratory Symptoms, Pharmacokinetics, and Biomarker Variations after Administration of either YPL-001, or Placebo in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease

Scientific Poster

2018 ATS – A Randomized, Double-Blind, Placebo Controlled, Multicenter Phase 2a Study to Assess Safety, Daily Respiratory Symptoms, Pharmacokinetics, and Biomarker Variations after Administration of either YPL-001, or Placebo in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease

Scientific Poster

Therapeutic Peptides for CNS Indications: Progress and Challenges

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2018 ASCPT – Oncology Drug Development: Phase I Case Studies in Healthy Volunteers

Presentation

2018 WORLD ADC – Immunogenicity Assessment of Antibody Drug Conjugates in Cancer Studies

Scientific Poster

2017 NCCR – The Role of Early Clinic Research/Clinical Pharmacology Trial Centers in Precision Medicine Research

Presentation

Müller’s Manoeuvre, an Autonomic Approach to the Treatment of Bronchoconstriction Relevance in Clinical Trials

Articles

Tracking the Sugar Rush: Incorporating Continuous Glucose Monitoring Into Multisite Early Clinical ResearchWith Type 2 Diabetes Subjects

Articles

Leveraging Non-Invasive Approaches in NAFLD and MASH Diagnosis and Clinical Research

Webinar

2018 World Vaccine Congress – A Multiplex qPCR Assay for Zika, Dengue, and Chikungunya Viruses (ZDC) to Support On-going Vaccine and Drug Efficacy Studies

Scientific Poster

Evaluating Cardiac Risk: Exposure Response Analysis in Early Clinical Drug Development

Articles

Evaluating Clinical Proarrhythmia Risk in Early Drug Development

White Papers

2018 ASCPT – Predicting MASH Related Screen Failure Rates in Patients With Renal Impairment

Scientific Poster

Best Practices for Evaluating Clinical Proarrhythmia Risk in Early Drug Development

White Papers

Development and Validation of an ELISA for the CK18-M30 Apoptosis Biomarker for MASH Drug Development

White Papers

A Multiplex qPCR Assay for Zika, Dengue, and Chikungunya Viruses (ZDC) to Support On-going Vaccine and Drug Efficacy Studies

Scientific Poster

Celerion Leadership in Therapeutic Areas

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Celerion Overview

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Immunogenicity Assessment of Antibody Drug Conjugates in Cancer Studies

Scientific Poster

Evaluation of HbA1c Screening During Outreach Events for Prediabetes Recruitment

Articles

2017 AAPS – Pegfilgrastim Case Study: Bridging Immunoassay and Direct Drug Coating Immunoassay Fail to Detect All Anti-Drug Antibodies Against Pegylated Protein

Scientific Poster

2017 EBF – Biomarkers of Glucose Metabolism in Human Plasma and Saliva

Presentation

2017 EBF – Specific Surrogate Matrix Development Significantly Improves Insulin Measurements and Abrogates Cross-Reactivity With its Analogues

Scientific Poster

2017 EBF – Fab Based High Sensitivity PK ELISA for the Detection of a Therapeutic Antibody Administered in Neurodegenerative Disease Treatment

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2017 EBF – Development of a Highly Sensitive Assay for the Detection of the Biomarker C-Peptide in Human Serum

Scientific Poster

Celerion Leadership in Data Management and Biometrics

Fact Sheet

2017 EBF – Determination of Ustekinumab in Human Serum Using High Sensitivity PK ELISA

Scientific Poster

High Sensitivity PK ELISA for Detection of Antibody in Neurodegenerative Disease

Scientific Poster

Leaders in Vaccine Development

Fact Sheet

Keys to Success in Biosimilar Bioanalytical Assay Development and Sample Analysis

Articles

Method establishment for discerned immunogenicity assessment of a recombinant glycoprotein containing nonhuman sialic acid Neu5Gc residues

Articles

Challenges and Solutions with Bioanalysis of Soluble Biomarkers: A Case Study for Non-Invasive MASH Biomarkers

White Papers

Why Biosimilar Developers Choose to Work with Celerion

Video

2017 Land O’Lakes – Development of High Sensitivity and High Throughput Immunoassays for PD-1 Cancer Immunotherapy

Scientific Poster

The Impact of Prediabetes on Early Clinical Metabolic Disease Studies

Articles

2017 DIA – SDTM/ADaM Compliant or Sufficient Submission for Legacy Studies

Scientific Poster

The Development of a Method for the Determination of Cortisol and 6-Beta-Hydroxycortisol in Human Urine Using 2-D Chromatography

Scientific Poster

Pharmacodynamic and Pharmacokinetic Assessment of Electronic Cigarettes, Combustible Cigarettes, and Nicotine Gum: Implications for Abuse Liability

Articles

A Fatty World: Exploring Racial Disparity in NAFLD/MASH

Articles

Saliva: A Reliable Sample Matrix in Bioanalytics

Articles

Immunoaffinity Coupled with Mass Spectrometry (IA-LC-MS/MS) as a Quantitative Tool for Bioanalysis of Ado-Trastuzumab Emtansine in Human Plasma

Scientific Poster

2017 AAPS NBC – LC-MS/MS Method for Quantitation of Physiological Levels of Glucagon in Human Plasma

Scientific Poster

2017 AAPS NBC – Immunoaffinity Coupled with Mass Spectrometry (IA-LC-MS/MS) as a Quantitative Tool for Bioanalysis of Ado-Trastuzumab Emtansine in Human Plasma

Scientific Poster

Enhancing the Pharmaceutical Properties of Peptides

Articles

Cardiovascular Safety Services

Fact Sheet

2017 WRIB – Evaluation of an ELISA Method Using Novel NanoLuc® Reporter and Its Comparison with Traditional Electrochemiluminecence Assay for the Measurement of Ranibizumab

Scientific Poster

2017 WRIB – Development and Validation of LC-MS/MS Methods for the Quantification of Biomarkers Tryptophan, Kynurenine and 3-Hydroxykynurenine in Human Plasma

Scientific Poster

2017 WRIB – Applicability of a NoviplexTM Blood-Plasma Sampling Device for the Analysis of Itraconazole

Scientific Poster

2017 ASCPT – Effectiveness of Community-Based HbA1c Screening as a Clinical Study Recruitment Tool

Scientific Poster

2017 ASCPT – Examining the Relationship Between Atherogenic Indices and the Non-Invasive Fibrosis Biomarker FIB4

Scientific Poster

2017 Asia TIDES – Accelerating Peptides into Human Studies: Drug Development and Regulatory Considerations

Presentation

Update and Trends on Pharmacokinetic Studies in Patients with Impaired Renal Function: Practical Insight into Application of the FDA and EMA Guidelines

Articles

No Effect of Omega-3 Carboxylic Acids on Pharmacokinetics/Pharmacodynamics of Warfarin or on Platelet Function When Co-administered with Acetylsalicylic Acid: Results of Two Phase I Studies in Healthy Volunteers

Articles

Evaluation of the Potential for Drug Interactions With Patiromer in Healthy Volunteers

Articles

Systemic Bioavailability and Dose Proportionality of Omega-3 Administered in Free Fatty Acid Form Compared With Ethyl Ester Form: Results of a Phase 1 Study in Healthy Volunteers.

Articles

A Novel NF-κB Inhibitor, Edasalonexent (CAT-1004), in Development as a Disease-Modifying Treatment for Patients With Duchenne Muscular Dystrophy: Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics in Adult Subjects

Articles

A Liquid Handling Robot for Robust and Reproducible Preparation of Standard and Quality Control Samples in Bioanalysis

Articles

Association of Testosterone and BDNF Serum Levels with Craving

Articles

Alcohol-Induced Changes in Methylation Status of Individual CpG Sites, and Serum Levels of Vasopressin and Atrial Natriuretic Peptide in Alcohol-Dependent Patients during Detoxification Treatment

Articles

Concomitant Medication Use in Progressive Supranuclear Palsy Clinical Trial Participants

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Novel NF-κB Inhibitor as Modifying Treatment for Duchenne Muscular Dystrophy

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PK Studies Trends in Impaired Renal Function Patients: Applying FDA/EMA Guidelines

Articles

2016 University of Wisconsin Online Course – CNS Pharmacology Target, Drug Abuse Liabilities and More

Presentation

2016 EBF – Comparison of Non-target Specific, Mono- and Bi-functional PK Assays Formats Targeting a Bispecific mAb

Scientific Poster

2016 EBF – A Hybrid Immunocapture-LC-MS/MS Method for the Determination of Humanized Monoclonal Antibody in Rat Plasma

Scientific Poster

2016 AAPS Annual – Development and Optimization of a Highly Specific and Sensitive Assay to Detect Acetylcholinesterase Activity and Its Inhibition

Scientific Poster

Comparing PK of Ketorolac Tromethamine: Sub-cu Infusion & Intramuscular Injections

Articles

2016 AAPS Annual – Development and Optimization of an Ultrasensitive Immunoassay Method Using Amplatto Technology for the Measurement of Protein X to Support Pharmacokinetic Studies

Scientific Poster

Early Drug Development: Assessment of Proarrhythmic Risk and Cardiovascular Safety

Articles

The Future of Biomarkers is Micro: the Emerging Role of Micro-RNAs in Metabolic Diseases

White Papers

2016 Outsourcing in Clinical Trials New Enland – Investigating Early Clinical Proof of Concept and NDA-enabling Clinical Pharmacology Package Studies

Presentation

2016 DIA Annual Meeting PharmaVOICE Interview with Nita Ichhpurani, Celerion and Dr. Thomas Marbury, Orlando Clinical Research Center

Video

Bioanalytical Challenges of Biosimilars

Articles

2016 ADA – A Novel Index to Identify Steady-State Glucose Infusion Rates during a Clamp

Scientific Poster

2016 ASMS – Resolution of Unexpected Reference Standard Components of 5R,S isoprostane F2a Type VI iPF2a-VI Using a Shallow UHPLC MS/MS Gradient

Scientific Poster

2016 ASMS – Bioanalytical LC-MS/MS Method for the Determination of a Vitamin E Analog in Human Plasma

Scientific Poster

Improved Pharmacokinetics of Sumatriptan with Breath Powered™ Nasal Delivery of Sumatriptan Powder

Articles

Highlights on Recent Peptide Achievements

Articles

2016 ASCPT – Triplicate ECGs are Sufficient in Obtaining Precise Estimates of QTcF

Scientific Poster

Pharmacokinetic Time Course Scaling of a Subcutaneously Administered Pegylated Peptide Conjugate for a First-in-Human Investigation

Articles

Population physiologically-based pharmacokinetic model incorporating lymphatic uptake for a subcutaneously administered pegylated peptide

Articles

NAFLD/MASH and Non-Invasive Biomarkers Predicting Fibrosis

White Papers

2016 Informa Early Clinical Development – Industry Academic Collaboration: A Key to Successful Involvement of Patients Early in Clinical Development

Presentation

2015 Society of Toxicology of Canada 47th Annual Symposium – Assessing Safety Risk in Early Clinical Studies: Science or Art?

Presentation

2015 JSCPT – Can Small Molecule Oncology Drugs Be Tested in Healthy Subjects?

Presentation

2015 Celerion-SNUH Symposium – Incorporating Early Assessments of Cardiovascular and CNS Safety into Early Clinical Studies

Presentation

Smear Count Simulation After Administration of Eurartesim® in Malaria Patients

Scientific Poster

2015 San Mateo & San Diego Clinical Discussion Forums – Human ADME Study Design Considerations in Healthy Subjects and in Patients

Presentation

2015 EBF – The Road to Functional Bioanalysis: Development and Validation of a Cell-Based Assay for Neutralizing Anti-Drug Antibody Analysis

Presentation

2015 EBF – A Cell-Based Assay for Detection of Neutralizing Antibodies against Peg-Filgrastim in Human Serum

Scientific Poster

2015 EBF – Method Development Strategies for Automation of Ligand Binding Assays

Scientific Poster

2015 EBF – Bioanalytical Determination of Human Insulin and Insulin Detemir in Human Plasma by Immunoenrichment and LC-MS/MS

Scientific Poster

2015 Houston Clinical Discussion Forum – Efficient Early Clinical Research to Achieve Clinical Proof-of-Concept Requires Patients

Presentation

Shaping Research for Proof of Concept

Articles

2015 AAPS – An LC MSMS Method was Developed and Validated for the Quantification of an Intact 9kDa Peptide in Animal Plasma Samples from a Toxicology Study

Scientific Poster

2015 AAPS – Assessment of a Pharmacokinetic Drug Interaction between Solithromycin and Digoxin

Scientific Poster

2015 AAPS – Development and Qualification of a Novel Integrated – ELISA Assay for the Measurement of Infliximab (IFX) and Antibodies to Infliximab (ATI) Assays to Support Post-Marketing Surveillance Studies

Scientific Poster

2015 AAPS – Evaluation and Validation of a Commercial ELISA Kit for the Detection of Antibodies to Pegylated Therapeutic Drug (Pegfilgrastim) in Human Serum for Use in Support of Clinical Studies

Scientific Poster

2015 AAPS – Development and Validation of a Specific ELISA Suitable for the Pharmacokinetic Measurement of Insulin Glargine and its Metabolites M1 and M2

Scientific Poster

2015 AAPS – LC-MS/MS Quantification of Propylene Glycol

Scientific Poster

2015 AAPS – A Validated Flow Cytometry Method for Absolute Quantification of CD34+ Hematopoietic Stem Cells with Extended Sample Stability

Scientific Poster

2015 AAPS – Incorporating Allometric Scaling Factors and Non-Linear Mixed-Effect Modeling to Predict Interindividual Variability in the Concentration vs. Time Course of a Pegylated Peptide following Subcutaneous Administration

Scientific Poster

2015 Safety Pharmacology Society Meeting – Drug-Induced Movement Disorders: Back Translation from the Clinic and Moving Forward from Animal Models

Presentation

2015 American Conference on Pharmacometrics – Population Physiologically Based Pharmacokinetic Model Incorporating Lymphatic Uptake for a Subcutaneously Administered Pegylated Peptide

Scientific Poster

2015 American Conference on Pharmacometrics – Modeling and Simulation of Piperaquine (PQ) after Administration of Eurartesim®

Scientific Poster

Follow the Yellow Brick Road: The Pathway for NAFLD and MASH Drug Development in Early Phase Clinical Trials

Articles

2015 DIA Annual Meeting – Interview with Dr. Pritchard, Celerion and Dr. Chee, KoNECT, PharmaVOICE

Video

The Expansion of the Therapeutic Applications of Peptides: Drivers and Challenges

Articles

Safety and Pharmacokinetics of Solithromycin in Subjects with Hepatic Impairment

Articles

Making a Change through Clinical Research

Articles

2015 DIA – Establishing Normal Ranges for ECG Intervals in a Normal Healthy Population

Scientific Poster

2015 DIA – Feasibility of Replacing the Thorough QT (TQT) Study with Intense ECG Data Collection in Early Clinical Studies

Scientific Poster

2015 HNC Exploratory Clinical Development World – QT Assessment: The New Paradigm, but Now What?

Presentation

2015 International Workshop on Clinical Pharmacology of HIV & Hepatitis – Effect of Ketoconazole on the Pharmacokinetics of Doravirine (MK-1439), a Novel Non-Nucleoside Reverse Transcriptase Inhibitor for the Treatment of HIV-1 Infection

Scientific Poster

2015 PHARMA SUG – Summing up – SDTM Trial Summary Domain

Scientific Poster

2015 PHARMA SUG – Evaluating SDTM SUPP Domain for AdaM – Trash Can or Buried Treasure

Scientific Poster

2015 TIDES – Intranasal Drug Delivery: Drug Development Considerations

Presentation

2015 Exl Pharma 2nd Clinical Trials Phase I & Phase IIA Summit – Driving Efficiency in Early Cardiac Safety Evaluation Using Highly Automated Systems vs. a Standard Semi-Automated Method

Presentation

2015 KSCPT – Early Clinical Development: Case Study of Davunetide on Translation from the Bench to the Clinic

Presentation

2015 US Japan Health Care Study Group – Adaptive and Innovative Study Designs to Accelerate Drug Development from First-In-Human to First-In-Patient

Presentation

2015 EASL's International Liver Congress – No Evidence of Pharmacokinetic Drug-Drug Interaction in Healthy Subjects Between Coadministered Grazoprevir (MK-5172)/Elbasvir (MK-8742) and Sofosbuvir

Scientific Poster

2015 WRIB – Unlocking Value of Flow Cytometry During Drug Development: Establishment of Whole Blood Sample Stability for Extended Analysis

Scientific Poster

2015 ASCPT – A TQT Study Confirms Early PK/PD Modeling That a Supratherapeutic Dose of Omarigliptin, a Once-Weekly DPP‑4 Inhibitor, Does Not Prolong the QTc Interval

Scientific Poster

2015 ENDO – XOMA 358, a Novel Treatment for Hyperinsulinemic Hypoglycemia: Safety and Clinical Pharmacology from the First in Human Trial

Scientific Poster

2015 Celerion's Dinner & Scientific Discussion Program – Fast to Patient: The Push For Earlier Signals of Efficacy in Clinical Research

Presentation

2015 Celerion's Dinner & Scientific Discussion Program – Efficient Clinical Pharmacology Study Designs

Presentation

2015 Metabolic Leaders’ Forum – Optimizing Early Phase Antidiabetic Drug Development

Presentation

Unlocking Value of Flow Cytometry During Drug Development: Establishment Of Whole Blood Sample Stability For Extended Analysis

White Papers

A Validated Method For Detection of CD34+ Hematopoietic Stem Cells With Extended Sample Stability

White Papers

Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Cabozantinib

Scientific Poster

TQT Study Confirms Early PK/PD: High Dose Omarigliptin Doesn’t Prolong QTc Interval

Scientific Poster

2015 Celerion’s Dinner & Scientific Discussion Program – Cardiovascular Safety in Evolution

Presentation

2015 Celerion’s Dinner & Scientific Discussion Program – Early Patient Studies in Evolution

Presentation

2015 Informa Phase I and IIa Clinical Trials – Emerging Early Clinical Research Capabilities in Asia-Pacific

Presentation

Metabolic Diseases

Video

Cardiac Safety Services

Video

Is South Korea the Next Emerging Early Phase Destination?

Articles

2014 European Congress of Clinical Microbiology and Infectious Diseases – Safety and Pharmacokinetics of Solithromycin in Subjects with Hepatic Impairment

Scientific Poster

2014 EBF – Integrating Automated Systems for Regulated Bioanalysis

Presentation

Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial

Articles

Intranasal NAP (davunetide) decreases tau hyperphosphorylation and moderately improves behavioral deficits in mice overexpressing α-synuclein.

Articles

Cardiovascular effects caused by increasing concentrations of diesel exhaust in middle-aged healthy GSTM1 null human volunteers.

Articles

Controlled exposure of humans with metabolic syndrome to concentrated ultrafine ambient particulate matter causes cardiovascular effects.

Articles

2014 Five Continent International Symposium on Drug Development – Preparing for Changing Cardiac Safety Regulations

Presentation

International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy 2014 – Age and Gender Effects on the Pharmacokinetics of HCV NS5A Inhibitor MK-8742

Scientific Poster

American Association for the Study of Liver Diseases 2014 – Pharmacokinetics of Co-Administered HCV Protease Inhibitor Grazoprevir (MK-5172) and NS5A Inhibitor Elbasvir (MK-8742) in Volunteers With End-Stage Renal Disease on Hemodialysis or Severe Renal Impairment Not on Hemodialysis

Scientific Poster

2014 REACTA Forum – How To Be a Global Player in Early Clinical Development?

Presentation

SGLT Inhibition in Patients with Type 1 Diabetes

Articles

2014 14th Annual Safety Pharmacology Society Meeting – Elements of a Phase I Study

Presentation

Quantitative analysis of bisphosphonates in biological samples

Articles

2014 National Institute for Health Research, Mental Health Research Network – Early Clinical Research in Mental Health: Working with the US TURNS Consortium

Presentation

2014 EuroPeptides – Lessons from an Intranasal, Neuroprotective Peptide, NAPVSIPQ. Why did it Fail?

Presentation

Allometric Scale Factors Predict Interindividual Variability of Pegylated Peptide

Scientific Poster

DIA 2015 Annual Meeting PharmaVOICE Interview with Dr. Pritchard, Celerion and Dr. Chee, KoNECT

Scientific Poster

Pulmonary Assessments of New Drugs to Treat Respiratory Disease

Video

2014 EBF – Determination of Octreotide In Human Plasma By LC-MS/MS

Scientific Poster

2014 EBF – Consideration Of Adsorption Issues During Sample Handling in Urine Bioanalysis

Scientific Poster

2014 EBF – Challenges In Using A Commercial Kit For Biomarkers Analysis

Scientific Poster

2014 EBF – Bioanalytical Determination of Treosulfan and its Active Metabolites

Scientific Poster

Peptide Bioanalysis In Urine, A Case Study

Case Study

2014 AAPS – Evaluation of the Effect of Food or Administration of a Proton Pump Inhibitor on the Single-Dose Plasma Pharmacokinetics of Cabozantinib in Healthy Adult Subjects

Scientific Poster

2014 AAPS – A Bioanalytical Method for Quantitation of Monoclonal Antibody Therapeutics in Animal Biofluids by Liquid Chromatography and Tandem Mass Spectrometry

Scientific Poster

2014 ACCP – An Introduction of the Fourth Year Pharmacy Student to the Drug Development Process and Applied Translational Medicine, a Phase I Clinical Research Rotation

Scientific Poster

2014 DIA Annual Meeting – PharmaVOICE interview with Dr. Olbertz and Dr. Lester focused on Cardiovascular Safety Services

Video

2014 Clinical Trial Oversight Summit: Outsourcing in Early Clinical Development: Keys to a Successful Partnership

Presentation

Flow Mediated Dilation

Video

2014 TIDES – Neuroprotection in preclinical models of Parkinson disease by the NAPVSIPQ peptide

Presentation

2014 ADA – Insulin Suppresses Fatty Acid Binding Protein and Omentin Levels

Scientific Poster

2014 PAGE – Modeling and Simulation of Dihydroartemisinin (DHA) after Administration of Eurartesim® (piperaquine tetraphosphate/DHA)

Scientific Poster

2014 World Diabetes Day_Celerion A Global CRO Leading Antidiabetic Drug Development Locally

Presentation

2014 PHARMA SUG – Evaluating the Benefits of JMP for SAS Programmers

White Papers

2014 PHARMA SUG – Adopted Changes for SDTMIG v3.1.3 and 2013 OpenCDISC Upgrades

Scientific Poster

Celerion's Symposia Series – Mind the Gap: Elements of a Bridging Strategy

Presentation

Celerion's Symposia Series – Diabetes and Drug Development

Presentation

Celerion's Symposia Series – Early Phase Clinical Research Signals of Efficacy in Developing Therapies for Diabetes, Obesity, and Metabolic Disorders

Presentation

Celerion's Symposia Series – Are You Ready for the Changing Cardiac Safety Regulations?

Presentation

Celerion's Symposia Series – Access to Patients Earlier in Clinical Development: Think Global

Presentation

2014 ASCPT – Pharmacokinetics of Omarigliptin (Mk-3102), A Once-Weekly Dipeptidyl Peptidase-IV (DPP-4) Inhibitor, in Patients With Renal Impairment

Scientific Poster

2014 American Statistical Association Conference on Statistical Practice – Skills for a Career in Applied Statistics

Scientific Poster

2014 American Statistical Association Conference on Statistical Practice – JMP Start Biostatisticians’ Quality Check on Analytical Results

Scientific Poster

2014 IBC's 6th Annual Asia TIDES – Trials and Tribulations for an Intranasal Peptide: Davunetide, lessons learned

Presentation

2014 Informa Phase I and IIa Clinical Trials – Effective Outsourcing of Clinical Pharmacology Studies in Europe

Presentation

The Development Of An ELISA Assay For The Determination Of Pegfilgrastim In Human Serum

White Papers

Highly Automated ECG Core Lab

Video

2014 Strategic Resource Management Conference – Productivity Improvement through Integrated Business Planning (IBP)

Presentation

Bioanalytical challenges in the development of biosimilars

Articles

Improving productivity and profitability of a bioanalytical business through sales and operation planning

Articles

Improved Pharmacokinetics of Sumatriptan With Breath Powered™ Nasal Delivery of Sumatriptan Powderr

Articles

Sensitive glucagon quantification by immunochemical and LC-MS/MS methods.

Articles

2013 AAPS Annual Meeting – Impact of CYP3A4 Inhibition and Induction on the Single-Dose Pharmacokinetics of Cabozantinib in Healthy Volunteers

Scientific Poster

2013 AAPS Annual Meeting – Pharmacokinetics and Pharmacodynamics of YKP10461 Following a First in Human Phase I Study in Healthy Participants

Scientific Poster

2013 AAPS Annual Meeting – Overcoming Adduct Formation to Develop and Validate an LC MSMS Method for the Quantitative Determination of a Human Proislet Peptide in Human Plasma

Scientific Poster

2013 AAPS Annual Meeting- Non-compartmental Analysis versus Target Mediated Drug Disposition Modeling Predictive Accuracy in Interspecies Scaling of Interferon Beta 1A

Scientific Poster

Absence of Clinically Relevant Drug-Drug Interaction between Odanacatib and Digoxin after Concomitant Administration.

Articles

2013 AAPS Annual Meeting – Method Development of an LC MSMS Assay for Therapeutic Dosages of Albuterol by Metered Dose Inhaler in Human Plasma

Scientific Poster

Randomized, Double-Masked, Placebo-Controlled Study to Assess the Ocular Safety of Mirabegron in Healthy Volunteers

Articles

Pharmacokinetics and Pharmacodynamics of the Antiplatelet Combination Aspirin (Acetylsalicylic Acid) Plus Extended-Release Dipyridamole Are Not Altered by Coadministration with the Potent CYP2C19 Inhibitor Omeprazole

Articles

Steady-state Bioavailability of Prescription Omega-3 on a Low-fat Diet is Significantly Improved with a Free Fatty Acid Formulation Compared with an Ethyl Ester Formulation: the ECLIPSE II Study

Articles

2013 REACTA Forum – Operating an Efficient and Profitable Clinical Trial Center in the US and Europe

Presentation

2013 HNC Exploratory Clinical Development World – What are the Most Significant Changes Effecting Early Clinical Development?

Video

2013 DIA Annual Meeting – Interview with Bruce Morimoto, PharmaVOICE

Video

2013 HNC Exploratory Clinical Development World – What are the Challenges of Developing Predictive Bio-markers for the Clinical?

Video

2013 HNC Exploratory Clinical Development World – What are the Solutions to Accelerate Early Clinical Development?

Video

2013 HNC Exploratory Clinical Development World – What are the Challenges in Assessing the Safety for a New Compound?

Video

61st ASMS Conference – A Sub-Picogram LC-MS/MS Method for the Analysis of Mometasone Furoate in Human Plasma

Scientific Poster

2013 HNC Exploratory Clinical Development World – Solving Challenges Faced in Early Clinical Development

Presentation

2013 HNC Exploratory Clinical Development World – Translational Medicine: Making the Right Candidate Selection

Presentation

2013 Clinical Trial Supply West Coast – Clinical Trial Supply Management: A Virtual Company Lessons Learned

Presentation

2013 TIDES – Considerations for Peptide Contract Manufacturing: Lessons Learned on Outsource Management

Presentation

2013 AAPS NBC – The Development and Validation of Methods for the Quantitation of Polyethylene Glycol in Serum via ELISA with Methoxy Terminal (mPEG) Detection Following the Evaluation of Commercially Available Kits

Scientific Poster

2013 PHARMA SUG – Flags for Facilitating Statistical Analysis Using CDISC Analysis Data Model

Scientific Poster

2013 PHARMA SUG – How to Make SAS® Drug Development More Efficient

Scientific Poster

The Development of an Elisa Assay for the Determination of PTH (1-34) in Human Plasma (EDTA) and for the Determination of Anti-PTH (1-34) Antibodies in Human Serum

White Papers

2013 WRIB – Unexpected Results for Sample Collection and Handling Stability Assessment for Sumatriptan in Human Plasma

Scientific Poster

The Development of an Elisa Assay for the Determination of Rituximab in Human Serum

White Papers

The Development of an Elisa Assay for the Determination of Cetuximab in Human Serum

White Papers

2013 ASCPT Annual Meeting – Multiple Doses of Odanacatib, a Novel Cathepsin K Inhibitor, Have No Influence on the Single-Dose Pharmacokinetics of Digoxin With Concomitant

Scientific Poster

2013 ASCPT Annual Meeting – Multiple Doses of Omega-3 PUFAs Do Not Alter the Pharmacokinetics of Simvastatin or the Antiplatelet Effect of ASA

Scientific Poster

2013 Informa Life Sciences 14th Annual Phase I & IIa Clinical Trials – Adaptive and Innovative Study Designs to Accelerate Drug Development from First-In-Human to First-In-Patient

Presentation

2013 Biosimilars Drug Development World Europe – Bioanalytical and Early Stage Clinical Strategies for Biosimilars

Presentation

2012 American Society of Hematology Annual Meeting and Exposition – ACE-536 Increases Hemoglobin in Healthy Postmenopausal Women: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study

Scientific Poster

2012 EBF 5th Open Meeting: Old Battles, New Horizons – Application of Differential Ion Mobility Mass Spectrometry to Peptide Quantitation

Scientific Poster

2012 EBF 5th Open Meeting: Old Battles, New Horizons – An Elisa for the Evaluation of the Relative Affinity of an ADA Response

Scientific Poster

2012 AAPS Annual Meeting – Prediction Accuracy of Allometric Approaches for Macromolecules: Application for Biosimilar Development

Scientific Poster

2012 AAPS Annual Meeting – Multiple-Dose Administration of a Free-Fatty Acid Formulation of Epa/Dha Has No Effect on the Pharmacokinetics or Pharmacodynamics of Single-Dose Warfarin

Scientific Poster

2012 AAPS Annual Meeting – A Fistful of Dollars and For a Little Bit More…? The Good, Bad, and Ugly of Supporting Human ADME Studies

Presentation

2012 AAPS Annual Meeting – Sterilization of Radiolabeled API in USP Compliant Clinical Pharmacology Unit Clean Room: Application to ADME and Microtracer Studies

Scientific Poster

2012 AAPS Annual Meeting – Naftifine Hydrochloride Does Not Prolong the Qtcf Interval in Healthy Subjects

Scientific Poster

2012 CAPRA Symposium – Nonclinical Biomarkers and their Translation to the Clinic

Presentation

2012 Annual Knowledge Summit – The Evolving Landscape of Human Research Protections – Phase I Perspective

Presentation

2012 ACCP Annual Meeting – Steady-State Bioavailability of EPA/DHA is Markedly Improved with a Free Fatty Acid Compared to an Ethyl Ester Formulation

Scientific Poster

The Benefits of On-Site Sterile Compounding in a USP Clean Room

Articles

2012 ACCP Annual Meeting – Assessment of Effect of Age on the Pharmacokinetics of Avanafil, a New, Potent, Selective PDE-5 inhibitor, in Male Subjects

Scientific Poster

2012 ACCP Annual Meeting – Effect of CYP3A4 Inhibitor Coadministration on the Pharmacokinetics of Avanafil, a New, Potent, Selective PDE-5 Inhibitor

Scientific Poster

2nd Annual Biosimilars Summit – Scientific Challenges for Development of Biosimilar Monoclonal Antibodies

Presentation

2012 Joint Statistical Meeting – Intersubject Variability in Pharmacokinectics and Subject Characteristics in Phase I Studies

Scientific Poster

2012 DIA Annual Meeting – Modeling and Simulation in Early Drug Development

Scientific Poster

2012 DIA Annual Meeting – Preparing to Share CDISC SDTM Data: A Practical Evaluation of Potential Error Sources

Scientific Poster

2012 APS – Validating Cloud

Presentation

2012 EBF 3rd Focus Meeting – Development, Validation & Application of ADA Isotype Specific Assays

Scientific Poster

2012 AAPS NBC – The Development and Validation of an Enzyme Immunoassay for the Determination of Exenatide (Exendin-4)

Scientific Poster

2012 ASMS – Simultaneous Quantitation of Hydrocodone and Metabolites Using UPLC-MS-MS

Scientific Poster

2012 PharmaSUG – Streamlining Regulatory Submission with CDISC/ADaM Standards for Non-standard Pharmacokinetic/Pharmacodynamic Analysis Datasets

Scientific Poster

2012 SAS Global Forum – Creating Pharmacokinetic Graphs using SAS/GRAPH

Scientific Poster

2012 AACR – A Randomized, Crossover, Phase 1 Study to Evaluate the Effect of a Strong CYP3A4 Inhibitor on Tivantinib (ARQ 197) Pharmacokinetics in Healthy Subjects

Scientific Poster

2012 ASCPT – A Novel Glycine Reuptake Inhibitor, Does Not Cause QTcF Prolongation in Healthy Male Volunteers at Therapeutic and Supratherapeutic Exposure

Scientific Poster

2012 ASCPT – A Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of a Clonazepam Oral Solution Versus Tablets in Healthy Adult Volunteers

Scientific Poster

2012 ASCPT – A Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of a Ramipril Oral Solution versus Tablet in Healthy Adult Volunteers

Scientific Poster

2012 ASCPT – Effect of Renal Insufficiency on the Pharmacokinetics of Avanafil, a New, Potent, Selective PDE-5 Inhibitor, in Male Subjects

Scientific Poster

2012 ASCPT – Effect of Hepatic Insufficiency on the Pharmacokinetics of Avanafil, a New, Potent, Selective PDE-5 Inhibitor in Male Subjects

Scientific Poster

2012 Biosimilars Drug Development World – Early Stage Studies of Biosimilars

Presentation

2012 ISC – Omeprazole, a potent CYP2C19 inhibitor, does not alter the pharmacokinetics or platelet aggregation of aspirin and dipyridamole in combination

Scientific Poster

Asian Biotechnology Company with CNS Compound

Case Study

European Biotechnology Company Seeking First-in-Human U.S. Clinical Study

Case Study

Support of CMC to IND for Novel First-in-Class Small Molecule Drugs

Case Study

Development of an LC-MS/MS Peptide Method

Case Study

Optimized LC-MS/MS Method for New Observed Metabolite

Case Study

Consistent Database Structure for Programs of Studies

Case Study

Protocol Study Design and Development for Generic Studies

Case Study

2011 JSCPT – Enriching Phase I Studies for Better Decision Making

Presentation

2011 EBF – Strategies to Improve Free Drug Tolerance in Anti-Drug Antibody Assays

Scientific Poster

2011 EBF – Comparison of MRM and MRM3 for the Quantitative Determination of Misoprostol Acid in Human Plasma

Scientific Poster

Impact of Intravenous Naltrexone on Intravenous Morphine-Induced High, Drug Liking, and Euphoric Effects in Experienced, Nondependent Male Opioid Users

Articles

2011 AAPS – Validation of an LC-MS/MS Method for the Determination of Dronedarone (Multaq®) in Human Plasma

Scientific Poster

2011 AAPS – Pharmacokinetic Data Submission in the CDISC Environment

Scientific Poster

2011 CPSA – Holy #$%@! What Have We Gotten Ourselves Into

Presentation

2011 JETRO – Enriching Phase I Studies for Better Decision Making

Presentation

A High Sensitivity Dual Solid Phase Extraction LC-MS/MS Assay for the Determination of the Therapeutic Peptide Desmopressin in Human Plasma

White Papers

A TFC MS/MS Method for the Determination of the Cholinesterase Sensitive Analyte Rivastigmine in Human Plasma

White Papers

Assessment of Extract Cleanliness Using Different On-Line Clean Up Selectivities for a Turbulent Flow Chromatography (TFC) – MS/MS Method for the Determination of a Common Decongestant Agent in Human Plasma

White Papers

2011 PhUSE – Leveraging Biomarkers in Early Clinical Drug Development for Metabolic Disease Therapies

Presentation

CenterWatch Weekly, Insider Insights: Celerion, A company profile

Articles

2011 JSM – Using PROC TEMPLATE to Convert SAS Data to Define.xml. Awarded first place in the poster competition sponsored by the Section of Statistical Programmers and Analysts of American Statistical Association

Scientific Poster

2011 Land O'Lakes – Utilizing Lean Sigma Methodologies

Scientific Poster

2011 Reid Bioanalytical Forum – Use of Dried Blood Spot Sampling for Stabilisation of Rivastigmine

Scientific Poster

Challenges in archiving electronic bioanalytical data supporting GLP studies in a CRO

Articles

2011 SSPA Webinar – Implementing CDISC Based Processes Solutions for Common Challenges

Presentation

2011 DIA – Intravenous Pharmacokinetics in Humans Using Low Dose 14C-Labeled Drug and Accelerator Mass Spectrometry

Presentation

2011 DIA – Treatments for Alzheimer’s Disease – Challenges in Early Clinical Research

Presentation

2011 EBF Focus Meeting – Quantitative LC-MSMS Analysis of Glucagon

Presentation

2011 EBF Focus Meeting – Feasibility Assessment for an Elisa Method for the Quantitation of a Therapeutic Human Antibody in Dried Blood Spot

Scientific Poster

2011 PAGE – Pharmacokinetic-pharmacodynamic (PK/PD) Modeling of the Effect of Intravenous (IV ) Doses of Anzemet® (dolasetron mesylate) and Its Metabolite (hydrodolasetron) on the QT Interval in Healthy Subjects

Scientific Poster

2011 AAPS NBC – The Development and Validation of Specific Ligand Binding Methods for the Determination of Parathyroid Hormone (1-34) and (1-84) in Human Plasma for Pharmacokinetic Sample Analysis

Scientific Poster

2011 PharmaSUG – Combining RTF Graphs

Articles

2011 PharmaSUG – A Non-Invasive Macro to Track Submission Metadata in SAS Drug Development

Articles

2011 PharmaSUG – Tracking Metadata within SAS Drug Development Using SDDPARMS

Articles

2011 PharmaSUG – Helping Students Become Effective Industry Statisticians: Supplementing Science with Data Savvy

Articles

2011 DIA Dried Blood Spot Sampling in the Industry – Assessment of Factors Influencing Method Precision in a Human Dried Blood Spot Assay for the Determination of a Novel Analyte

Scientific Poster

Evaluation of Male Reproductive Safety During Clinical Development

White Papers

2011 SAS HLSC – A Streamlined Data Capture and Exchange Partnership that Delivers Faster Decisions

Presentation

2011 DIA Cardiovascular Safety – QTcF Postural Changes as Positive Control for TQT Studies

Presentation

2011 SAS Global Forum – Non-invasive Macro to Track Submission Metadata in SAS® Drug Development

Scientific Poster

Celerion gets USP OK for Ph I cleanroom

Articles

2011 ASCPT – Pharmacokinetics, Pharmacodynamics, and Safety of a Supra-Therapeutic

Scientific Poster

2011 ASCPT – Investigating Ethnic Differences In Qtcf Response To Moxifloxacin

Scientific Poster

2011 ASCPT – A Randomized, Double-Blind Study to Assess Serum Transaminase Elevations and Antibody Formation

Scientific Poster

2011 ASCPT – Exploring Gender Differences in QTcF Response to Moxifloxacin in a Randomized

Scientific Poster

The Relative Bioavailability of Morphine Sulfate and Naltrexone Hydrochloride Extended Release Capsules (EMBEDA)

Articles

2010 EBF – Exploring Quantification of Peptides: Measurement of Glucagon in Human Plasma by LC-MS/MS

Scientific Poster

2010 EBF – Hemolyzed Sample Evaluation

Presentation

2010 EBF – Case Studies in Haemolysed Plasma Assessment for Bioanalytical Method Validation Using LC-MS/MS

Scientific Poster

2010 EBF – Assessment of Factors Influencing Method Precision in a Human Dried Blood Spot Assay for the Determination of a Novel Analyte

Scientific Poster

2010 Joint Statistical Meeting – Harmonizing Data Processes with CDISC Family of Standards at Global CRO

Presentation

KOLN/KGIN Channel 10/11 Lincoln, Nebraska: BryanLGH Teams up with Celerion to Provide Dedicated Hospital Beds for Phase I Studies

Video

2010 AAPS – Comparative Bioavailability Study of Three Dosage Forms of Levothyroxine Sodium Tablets Following Single Doses in Healthy Subjects

Scientific Poster

2010 AAPS – Pharmacokinetics and Pharmacodynamics of Subcutaneously (SC) Administered Doses of BA058, A Bone Mass Density Restoring Agent in Healthy Postmenopausal Women

Scientific Poster

2010 AAPS – Determination of Screening Cut Point, Specificity Cut Point, And Sensitivity of an Anti-Drug Antibody Bridging ELISA

Scientific Poster

2010 AAPS – A Thorough QT Assessment of Cetrorelix Pamoate Following Intramuscular Administration in Healthy Subjects

Scientific Poster

2010 AAPS – A Randomized, Open-Label, Single-Dose Crossover Study to Assess the Effects of Atorvastatin or Valsartan Co-Administration on the Pharmacokinetics of Naltrexone HCL Sustained-Release Tablets in Healthy Adult Subjects

Scientific Poster

2010 AAPS – A LC-MS/MS Method for the Quantitation of Ibuprofen, Phenylephrine, Chlorpheniramine, and Phenylephrine-Succinate in Rat Plasma

Scientific Poster

2010 AAPS – A High Throughput LC-MS/MS Method for the Quantitation of Voriconazole in 0.05 mL of Human Plasma

Scientific Poster

2010 AAPS – Assessment of Analyte Losses in a Human Dried Blood Spot Assay for the Determination of Indapamide

Scientific Poster

How to Improve Efficiency and Productivity of Statistical Output

Recorded WebEx

2010 EORTC-NCI-AACR – Coadministration of a CYP3A4 Inhibitor (Ketaconazole) Increased the Bioavailability of CS-7017 but Did Not Affect Tolerability: Results from an Open-label, Phase I, Two-way Crossover Clinical Study in Healthy Subjects

Scientific Poster

Evolution of the Thorough QT/QTc Study

Articles

Harmonizing Data Processes with the CDISC Family of Standards at a Global CRO

Recorded WebEx

Hybrid Phase I/ ECG Core Lab: Key to Cost-Effective Thorough QT Studies

Fact Sheet

2010 ICAAC – Determination of the Effect of Age and Gender on the Pharmacokinetics and Tolerability of a Single Dose of Finafloxacin HCl in Healthy Volunteers

Scientific Poster

Managing Primary IND Applications with the FDA

Articles

A Closer Look at the MHRA

Articles

Biomarkers – Unlocking Value in Early Drug Development

White Papers

2010 Joint Statistical Meeting – Improve Efficiency and Productivity of Statistical Output

Presentation

Validation of an LC-MS/MS Method for the Determination of Ribavirin in Human Plasma (EDTA)

White Papers

Method Validation of an LC-MS/MS Method for the Determination of Gemcitabine and 2'-deoxy-2', 2'Difluorouridine (dFdU) in Tetrahydrouridine (THU)-Treated Plasma

White Papers

Managing Clinical Trial Application (CTA) Acceptability to Support Phase I Clinical Studies in the United Kingdom

White Papers

The Development and Validation of Two High Through-Put Methods for the Determination of Biomarkers IFG-1 and IGFBP-3 in Human Plasma

White Papers

Determining the Preclinical Toxicokinetic Comparability for a Biosimilar Drug

White Papers

2010 Biotech – A Novel Approach to Cost Effective Thorough QT Studies Utilizing a Highly Automated Hybrid Phase I/ ECG Core Laboratory

Scientific Poster

2010 PAGE – Population Pharmacokinetic Meta Analysis: Inhibition by Quinidine of the First-Pass and Systemic Metabolism of Dextromethorphan to Dextrorphan

Scientific Poster

2010 Dried Blood Spots – Assessment of Analyte Losses in a Human Dried Blood Spot Assay for the Determination of Indapamede

Scientific Poster

2010 DIA – Improve Efficiency and Productivity of Statistical Output

Scientific Poster

2010 ASMS – Development of a Method for the Quantification of Fluorouracil and Flucytosine in Human Plasma

Scientific Poster

2010 ASMS – A Highly Selective and Sensitive LC-MS/MS Method for Analysis of Glucagon in Human Plasma

Scientific Poster

2010 ASMS – A Highly Sensitive Method for the Quantitation of Testosterone and Dihydrotestosterone in Human Serum via LC-MS/MS

Scientific Poster

2010 AAPS NBC – The Development and Validation of Two High Through-Put Methods for the Determination of Biomarkers IGF-1 and IGFBP-3 in Human Plasma

Scientific Poster

2010 PAGE – Population Pharmacokinetic and Pharmacodynamic Meta Analysis of Zenvia: Modeling of QT Prolongation

Scientific Poster

2010 PAGE – Modeling and Simulation of Drug X and its Metabolite in Plasma and Urine

Scientific Poster

2011 DIA Dried Blood Spot Sampling in the Industry – Feasbility Assessment for an Elisa Method for the Quantitation of a Therapeutic Human Antibody in Dried Blood Spots

Scientific Poster

Outsourcing Under the Microscope: As Some Companies Tighten Their Belts, CROs Across the Globe are Enjoying this Growing Business Trend

Articles

2010 ASCPT – Population Pharmacokinetic and Pharmacodynamic Analysis of Pegloticase Administered by Intravenous Infusion in Two Dose Regimens to Subjects with Chronic Gout

Scientific Poster

2010 ASCPT – Ethnicity and the ECG

Scientific Poster

Fast-to-Patient: Creative Strategies for Quick Demonstration of Clinical Proof-of-Concept

Articles

How Modeling and Simulation Can Help in Obtaining More Information from a QT/QTc Study

White Papers

MDS Follows the Critical Path – and Sees Benefits

Articles

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