Population Pharmacokinetics; Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Population Pharmacokinetics." This guidance assists sponsors in the application of population pharmacokinetics (population PK) during the drug development process to inform drug use and includes FDA's current thinking on the data and model requirements for population PK analyses submitted as part of new drug applications (NDAs), biologic license applications (BLAs), and abbreviated new drug applications (ANDAs). This guidance also provides expectations regarding the format and content of the population PK report, as well as any labeling recommendations resulting from such analyses. This guidance finalizes the draft guidance of the same title issued on July 12, 2019.
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