| On February 4th, 2022, the FDA announced the availability of a final guidance for industry entitled Population Pharmacokinetics. This final guidance is intended to assist sponsors and applicants of new drug applications (NDAs), biologics license applications (BLAs), abbreviated new drug applications (ANDAs), and investigational new drug (IND) applications in the application of population pharmacokinetic (PK) analysis. Drug concentrations can vary significantly among individuals who are following the same dosing regimen. This variability can be attributed to intrinsic factors, such as differences in body weight, presence and extent of liver or renal impairment, or the presence of genetic polymorphisms, or to extrinsic factors, such as effects of food on drug absorption or concomitant medications that can interact with the administered drug's absorption and/or metabolism. In some cases, intrinsic or extrinsic factors lead to clinically relevant changes in drug concentrations that require clinical management strategies, such as a change in the dose or dosing regimen. Population PK analysis is a well-established, quantitative method that can explain some of the variability in drug concentrations among individuals, by integrating all relevant PK information across a range of doses and populations to identify factors that can affect a drug's exposure. These analyses, in turn, can inform strategies to select initial dosage regimens, manage dosing and administration for a given subpopulation, plan subsequent studies, or support labeling. Adequate population PK data collection and analyses submitted in marketing applications have in some cases alleviated the need for postmarketing requirements or postmarketing commitments. The focus of this guidance is on the use of this approach in explaining the variability in drug concentrations observed among human trial subjects from intrinsic factors, extrinsic factors, differences in dosing, and routes of administration. This guidance includes common applications of population PK analysis to inform drug development and drug use as illustrative examples. This guidance also includes the FDA's current thinking on the data and model submissions to support regulatory decisions, recommendations on how to incorporate information from population PK analyses in labeling, and the general expectations regarding the format and content for population PK reports submitted to the Agency. The "Population Pharmacokinetics" guidance is available at https://go.usa.gov/xtdZ4. Please refer to the final guidance for more details. To support transparent communication and dissemination of FDA guidance documents, FDA also provides Guidance Snapshots and podcasts as communication tools to provide highlights from guidance documents using visuals and plain language. Please find the Guidance Snapshot and podcast for the Population Pharmacokinetics guidance here: https://www.fda.gov/drugs/guidances-drugs/guidance-snapshot-pilot. |
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