Guidance for Industry Pharmacokinetics

FDA Guidance for Industry. Pharmacokinetics in Patients with Impaired Hepatic Function Study Design, Data Analysis and Impact on Dosing and Labelling. Rockville, MD FDA, 1999. 

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]. 

Center for Drug Evaluation and Research (CDER). Guidance for Industry. Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application, Feb. 1,1987. 

Food and drug administration. Guidance for industry Population pharmacokinetics, available at http //www.fda.gov/cder/guidance/1852fnl.pdf accessed November 10,... 

Guidance for Industry. Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency. Draft Guidance, http //www.fda.gov/cber/ gd lns/igi vimmuno.pd f... 

Due to the variability in the pharmacokinetic parameters seen in earlier studies, no formal sample size justification was given for 12 subjects per population. However, according to the draft guidance for industry by the US FDA 12 subjects is the typical minimum sample size for a bioavailability comparison (US FDA December 1978, US FDA December 2002). This was fulfilled here for each of the strata male, female, younger, elderly. 

EU CPMP (1999) Note for Guidance on Modified Release Oral and Transdermal Dosage Forms Section II (Pharmacokinetic and Clinical Evaluation) July 1999 US FDA Guidance for Industry Food-Effect Bioavailability and FED Bioequivalence Studies December 2002... 

The Guidance for Industry Population Pharmacokinetics clearly states that any type of population pharmacokinetic (PK) analysis should be defined in a protocol (7). The justification for this is that objectivity should be retained through prespecification of all procedures and methodologies that will be used. In the pharmaceutical industry this protocol usually takes the form of a plan for the analysis, either produced as part of the clinical trial protocol or as a separate document. 

Guidance for Industry. Population Pharmacokinetics, 1999. Available from http // www.fda.gov/cder/guidance/ (cited March 7, 2004). 

US Food and Drug Administration, Guidance for Industry Population Pharmacokinetics. US Department of Health and Human Services, February 1999. 

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