The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls | FDA

The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls | FDA

FDA Announces Draft Guidance on Physiologically Based Pharmacokinetic Analyses

The Food and Drug Administration announced the availability of the draft guidance for industry, The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls. This guidance provides current agency thinking on approaches for mechanistic modeling of small molecule drug products to promote timely approval of safe, effective, and high quality medicines. Mechanistic modeling for biopharmaceutics applications provides both industry and regulators a new tool in assessing drug applications. When a sponsor submits a drug application, biopharmaceutics modeling could inform drug development of in vivo responses due to formulation alterations, which in turn supports clinically relevant decision making. In silico approaches such as this would ultimately reduce the long-term burden on both industry and regulators. The guidance provides high-level workflows and uses cases that would be applicable to a wide variety of scenarios. FDA recognizes that the guidance does not discuss all cases but recognizes it is important to provide this preliminary thinking to the public. FDA has opened a public docket for stakeholders, including scientific and medical communities, to offer comments on this mechanistic modeling approach. You may submit your comments to this public docket, Docket No. FDA-2020-D-1517, by November 30, 2020. The agency will evaluate these comments and data and will consider updates to the document. Please refer to the public docket for additional details. This guidance is the result of a major collaboration between CDER’s Office of Pharmaceutical Quality, Office of Translational Sciences, and Office of Generic Drugs.