Zdrowie i gospodarka · 18/09/1997

Draft Guidance for Industry on Population Pharmacokinetics; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Population Pharmacokinetics.'' This draft guidance is intended to provide recommendations regarding the use of population pharmacokinetics in the drug development process. It summarizes scientific and regulatory issues that should be addressed during the conduct of population pharmacokinetic studies/analyses.