This guidance makes recommendations on the use of population pharmacokinetics in the drug development process to help identify differences in drug safety and efficacy among population subgroups. It summarizes scientific and regulatory issues that should be addressed using population pharmacokinetics. The guidance discusses when to perform a population pharmacokinetic study and/or analysis; how to design and execute a population pharmacokinetic study; how to handle and analyze population pharmacokinetic data; what model validation methods are available; and how to provide appropriate documentation for population pharmacokinetic reports intended for submission to the FDA. Although the information in this guidance for industry focuses on population pharmacokinetics, the principles discussed here are equally applicable to population pharmacodynamic and toxicokinetic studies.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.