Guidance for industry on Population Pharmacokinetics; availability. Food and Drug Administration, HHS.  Notice.
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.
D003257:Consumer Product Safety; D006801:Humans; D010599:Pharmacokinetics; D011159:Population Surveillance / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration