Drugs
Clinical Pharmacology
Below is a sortable listing of Clinical Pharmacology Guidances
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Draft Guidance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
|
Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies (PDF - 531KB)
|
Draft Guidance
|
02/17/11
|
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Draft Guidance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Draft Guidance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Draft Guidance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Draft Guidance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
|
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