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Renal/Hepatic Impairment Pharmacokinetics (PK) Study

Clinical pharmacology studies, such as ADME, drug-drug interaction (DDI) and renal/hepatic impairment pharmacokinetic (PK) studies can provide important data to support new drug applications (NDAs). While ADME and DDI studies typically enroll healthy volunteer participants, renal/hepatic impairment PK studies require patients, which often adds a degree of complexity to the study design and conduct.

Celerion understands the unique nature of renal and hepatic insufficiency patient populations and manages these specialized PK studies to efficiently and effectively complete your studies on time and with excellent quality data through our extensive US-EU site network. Please see below a wealth of resources that highlight our experience and expertise managing renal/hepatic impairment PK studies.

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Leverage Our Renal & Hepatic Impairment Pharmacokinetic Study Experience

Product Labeling Studies

Optimizing Renal and Hepatic Impairment Clinical Trials

Safety and Pharmacokinetics of Solithromycin in Subjects with Hepatic Impairment

Effect of Renal and Hepatic Impairment on the Pharmacokinetics of Cabozantinib (2016)

Moderate Hepatic Impairment Does Not Affect Doravirine Pharmacokinetics (2017)

Optimizing Early Clinical Trials in Special Populations

Revised Renal Impairment PK Study Guidance: Key Takeaways

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

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

Update and Trends on Pharmacokinetic Studies in Patients with Impaired Renal Function: Practical Insight into Application of the FDA and EMA Guidelines (2017)

Impact of the FDA’s Revised Draft Guidance on Renal Impairment PK Studies—Trends, Challenges and Solutions