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Drugs

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Clinical Pharmacology

Below is a sortable listing of Clinical Pharmacology Guidances

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Category	Title	Type	Date
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Pharmacology	Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363KB)	Draft Guidance	02/08/05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	General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (PDF - 37KB)	Draft Guidance	11/01/98
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in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 319KB)	Draft Guidance	03/22/10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Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 324KB)	Draft Guidance	11/01/04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Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations (PDF - 827KB)	Draft Guidance	02/17/12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

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