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𝗧𝗵𝗲 𝗠𝗮𝗻𝘆 𝗙𝗮𝗰𝗲𝘀 𝗼𝗳 𝗕𝗶𝗼𝗲𝗾𝘂𝗶𝘃𝗮𝗹𝗲𝗻𝗰𝗲

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Scientific Poster

No More Guesswork: The Ideal eGFR Formula for Optimized Healthy Volunteer Study Enrollment

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Articles

QT Myopia and Cardiac Safety

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Challenges in Biosimilar Bioanalytical Assays and Sample Processing

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Seeing Through the MIST: Metabolite Identification and Profiling Strategies

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White Papers

A Fully Automated Workflow for Gyrolab Assays

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Video

AAPS eChalk Talk – Saliva – A Reliable Sample Matrix in Bioanalytics

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Scientific Poster

A Creative Cocktail Drug-Drug Interaction Study to Evaluate the Effect of Sparsentan at Steady State on the PK of CYP & Transporter Substrates

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Scientific Poster

Power to the People: Estimating Sample Sizes for No Effect Drug-Drug Interaction Studies with Sensitive CYP and Transporter Substrates

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Fact Sheet

Lumbar Puncture & Cerebrospinal Fluid Sampling

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Fact Sheet

De-Risking and Optimizing First-in- Human Studies

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Case Study

A Hepatic Impairment Study for a Drug with a Long Half-Life; Aggressive Enrollment Timelines at a European Site

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Case Study

Navigating Enrollment & Central Lab Challenges in a Large Pharmacokinetic Study with Severe Renal Impairment

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Case Study

A Renal Impairment Study Evaluating Plasma and Intracellular (PBMC) Pharmacokinetics

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Fact Sheet

Bioanalytical Brochure

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Fact Sheet

Supporting GLP-1 Receptor Agonist & Weight Reduction Drug Development

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Scientific Poster

Optimization of Critical Steps for Measuring Immunomodulatory Therapeutic PD Effects

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Scientific Poster

Best Practices for Receptor Occupancy Assays in Clinical Sample Analysis

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Scientific Poster

Predictive Value of Nonclinical ADME Findings for Clinical Excretion Routes

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Scientific Poster

Safety, Tolerability and PK of SM17 in Healthy Volunteers

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Scientific Poster

A Cocktail DDI Study

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Improving Drug Tolerance in Anti-Drug Antibody (ADA) Assay Using PandA Method – Case Studies

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Scientific Poster

Bringing Unstable Flow Cytometry Assays Closer to the Patient

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Advancing PBMC Isolation for ELISPOT Analysis

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Advancing Whole Blood Stabilization Techniques for Immunological Analytical Outcomes

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Scientific Poster

Evaluating Singlicate Analysis for Cell-Based Neutralizing Antibody Assays

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Scientific Poster

Predictive Value of Nonclinical ADME Findings for Clinical Excretion Routes

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Fact Sheet

Drug Development for Women’s & Men’s Health

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Fact Sheet

Clinical and Bioanalytical Biologics Experience & Expertise

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Fact Sheet

Supporting Inhaled Drug Development

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Fact Sheet

Pulmonary Sampling Techniques & Sample Analysis

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Fact Sheet

Immune Challenge Models For Drug Development

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Articles

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

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Articles

ASCPT 2024 Abstract – MRX-5LBT Photosafety

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Articles

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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Video

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

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Fact Sheet

Peptide Drugs: Clinical & Bioanalytical Drug Development

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Fact Sheet

Clinical and Bioanalytical Oligonucleotide Experience and Expertise

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Fact Sheet

Clinical and Bioanalytical Support for Monoclonal Antibody Drugs

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Fact Sheet

Leaders in Early Metabolic Disease Studies

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Presentation

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

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Presentation

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

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Podcast

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

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Webinar

AAV8 Shedding Assay to Support Gene Therapy Clinical Trials

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Articles

Development of 24-Hour Rhythms in Cortisol Secretion Across Infancy

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Scientific Poster

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

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Webinar

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

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Case Study

Case Study: Bioanalytical Support of Oncology Studies

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Fact Sheet

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

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Fact Sheet

Leaders in Biosimilars

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Articles

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

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Articles

Innovative Approaches to Optimize Clinical Transporter Drug–Drug Interaction Studies

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Fact Sheet

Comprehensive Cardiovascular Safety and ECG Core Laboratory Services

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Scientific Poster

Predictive Value of Nonclinical ADME Findings for Clinical Excretion Routes

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Scientific Poster

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

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Articles

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

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Scientific Poster

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

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Fact Sheet

Leverage Our Regulatory Experts for Pre-IND and IND Support

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Scientific Poster

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

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Scientific Poster

Low Cut Points: Where Has Our Biological Variability Gone?

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Scientific Poster

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

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Scientific Poster

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

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Articles

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

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Scientific Poster

AAV8 Shedding Assay to Support Gene Therapy Clinical Trials

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Scientific Poster

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

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Scientific Poster

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

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Scientific Poster

Pharmacokinetic and Pharmacodynamic Relationships of Intranasally Administered and Intramuscularly Injected Epinephrine

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Fact Sheet

Expert Drug-Drug Interaction Study Design and Conduct

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Fact Sheet

Food Effect Study Best Practices

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Fact Sheet

Leverage Our Renal/Hepatic PK Study Experience & Expertise

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Fact Sheet

Leaders in Bioequivalence and Bioavailability Studies

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Articles

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

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White Papers

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

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Fact Sheet

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

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Fact Sheet

Celerion: Accelerating Therapeutic Futures with Molecular Biology Services

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Webinar

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

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Scientific Poster

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

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Podcast

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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Webinar

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

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Scientific Poster

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

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White Papers

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

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White Papers

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

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Video

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

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Webinar

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

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Webinar

Onsite Pharmacy Compounding for Your Phase 1 Clinical Study Webinar

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Fact Sheet

Global Cell and Gene Therapy Services Overview

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Presentation

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

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Articles

The Impact of N-nitrosamine Impurities on Clinical Drug Development

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White Papers

Refining Transporter DDI Studies with Endogenous Biomarkers

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Articles

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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Video

Celerion’s Zurich Bioanalytical Lab Tour

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Articles

The Pioneering Tech Speeding Up Drug Development

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Video

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

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Scientific Poster

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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Scientific Poster

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

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Scientific Poster

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

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Scientific Poster

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

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Scientific Poster

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

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Fact Sheet

Product Labeling Studies

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Video

Celerion’s Lincoln Bioanalytical Lab Tour

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White Papers

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

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Scientific Poster

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

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Scientific Poster

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

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Scientific Poster

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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Scientific Poster

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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Presentation

2021 Oxford Biomarkers – Biomarkers: Biology vs Bioanalysis

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Scientific Poster

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

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Scientific Poster

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

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Articles

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

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White Papers

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

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White Papers

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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Video

Onsite Pharmacy Compounding for Your Phase 1 Clinical Study

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Fact Sheet

Celerion Overview Brochure

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Case Study

Partnering with Large Pharmaceutical Companies

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Case Study

Partnering with Biotechnology Companies

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Case Study

IND Support for Asian Biotech

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Case Study

EU Biotech Needs First-in-Human FDA Support

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Case Study

High Throughput Bioanalytical Analysis

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Scientific Poster

Making Virtual Trials a Reality

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White Papers

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

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