| Title and Format |
Type |
Issue Date |
| Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling (PDF - 363 KB) |
Draft |
Issued 2/7/05 |
| Drug Interaction Studies--Study Design, Data Analysis, and Implications for Dosing and Labeling (PDF - 253 KB) |
Draft |
Issued 9/11/2006 |
| Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro (PDF - 109 KB) |
Final |
4/1997 |
| Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications (PDF - 221 KB) |
Final |
5/5/2003 |
| Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application (PDF - 519 KB) |
Final |
2/1987 |
| General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products (PDF - 37 KB) |
Draft
|
11/1998 |
| In Vivo Drug Metabolism/Drug Interaction Studies - Study Design, Data Analysis, and Recommendations for Dosing and Labeling (PDF - 44 KB) |
Final |
11/24/1999 |
| Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 222 KB) |
Final
|
Posted 5/30/2003 |
| Pharmacokinetics in Patients with Impaired Renal Function (PDF - 128 KB) |
Final |
5/14/1998 |
| Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 324 KB) |
Draft |
10/29/2004 |
| Population Pharmacokinetics (PDF - 135 KB) |
Final |
2/1999 |
