Regulatory Guidance

U.S. Department of Health and Human Services, FDA. Guidance for Industry: Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro. April 1997. URL: http://www.fda.gov/cder/guidance/clin3.pdf [25 October 2005].

U.S. Department of Health and Human Services. FDA. Guidance for Industry: Exposure-Response Relationships—Study Design, Data Analysis, and Regulatory Applications. May 2003. URL: http://www.fda.gov/cder/guidance/5341fnl.pdf. [25 October 2005].

U.S. Department of Health and Human Services. FDA. Guidance for Industry: Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application. February 1987. URL: http://www.fda.gov/cder/guidance/ old071fn.pdf [25 October 2005].

U.S. Department of Health and Human Services. FDA. Guidance for Industry: In Vivo Drug Metabolism/ Drug Interaction Studies—Study Design, Data Analysis, and Recommendations for Dosing and Labeling. November 1999. URL: http://www. fda.gov/cder/guidance/2635fnl.htm [25 October 2005].

U.S. Department of Health and Human Services. FDA. Guidance for Industry: Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling. May 2003. URL: http:// www.fda.gov/cder/guidance/3625fnl.pdf [25 October 2005].

U.S. Department of Health and Human Services. FDA. Guidance for Industry: Pharmacokinetics in Patients with Impaired Renal Function. May 1998. URL: http://www.fda. gov/cder/guidance/1449fnl.pdf [25 October 2005].

U.S. Department of Health and Human Services. FDA. Guidance for Industry: Population Pharmacokinetics. February 1999. URL: http://www.fda.gov/cder/guidance/1852fnl.pdf [25 October 2005].

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