Drugs

Clinical Pharmacology

Below is a sortable listing of Clinical Pharmacology Guidances

CategoryTitleTypeDate
Clinical Pharmacology Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363KB) Draft Guidance 02/08/05
Clinical Pharmacology Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (PDF - 221KB) Final Guidance 05/05/03
Clinical Pharmacology Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application  (PDF - 519KB) Final Guidance 02/01/87
Clinical Pharmacology Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 319KB) Draft Guidance 03/22/10
Clinical Pharmacology Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 222KB) Final Guidance 05/30/03
Clinical Pharmacology Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 324KB) Draft Guidance 11/01/04
Clinical Pharmacology Population Pharmacokinetics (PDF - 135KB) Final Guidance 02/01/99
Clinical Pharmacology Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations (PDF - 827KB) Draft Guidance 02/17/12
Clinical Pharmacology Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling (PDF - 131KB) Final Guidance 01/29/13
Clinical Pharmacology General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (PDF - 375KB) Draft Guidance 12/08/14

Page Last Updated: 02/23/2016
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