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The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.
FDA published draft guidance on July 11, 2019 for sponsors of new drug applications and biologics license applications on how to apply population pharmacokinetic (population PK) analysis, which is used in therapeutic individualization such as tailored dosing. Population PK data collection and analysis may alleviate the need for postmarketing requirements or postmarketing commitments, according to FDA.
The guidance lists common applications of population PK analysis to provide sponsors with illustrative examples. FDA provides data and model requirements, recommendations on drug labeling based on population PK analysis, and the format and content of population PK reports. Specifically, the guidance discusses selecting dosing regimens, sample sizing and scheme requirements, exposure metrics, pediatric study designs, and drug-drug interactions. Data topics discussed include study subjects, sampling schedules, preliminary examination of data, model development and validation, and simulations based on population PK models.
Comments on the guidance are being accepted through September 11, 2019.