Guidance for industry on Population Pharmacokinetics; availability. Food and Drug Administration, HHS. Notice.

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Abstract

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Population Pharmacokinetics." This guidance provides recommendations to pharmaceutical industry scientists, who have long been interested in the application of population pharmacokinetics, during the new drug development, safety and efficacy evaluation, and approval processes.

MeSH Term

Consumer Product Safety
Humans
Pharmacokinetics
Population Surveillance
United States
United States Food and Drug Administration

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