FDA Releases Final Guidance for Industry titled “Physiologically Based Pharmacokinetic Analyses--Format and Content”

On August 31, 2018, the U.S. Food and Drug Administration (FDA) has announced the availability of the final guidance entitled “Physiologically Based Pharmacokinetic Analyses — Format and Content.” This guidance outlines the recommended format and content of physiologically based pharmacokinetic (PBPK) data and analyses submitted in investigational new drug  applications(INDs), new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) to enable efficient and consistent FDA review.

A PBPK analysis uses models and simulations that combine physiology, population, and drug characteristics to mechanistically describe the pharmacokinetic (PK) and/or pharmacodynamic behavior of a drug. Sponsors can use PBPK model predictions throughout a drug’s life cycle to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, and to support dosing recommendations in product labeling. Because of the lack of regulatory guidance, the format and content of PBPK analysis reports sponsors submit to FDA vary significantly. The goal of this guidance is to standardize the content and format of these reports to facilitate FDA’s efficient assessment, consistent application, and timely decision-making during regulatory review. As PBPK models are highly complex, sponsors anticipating the application of PBPK modeling in their drug development program should communicate early with the FDA.

Please refer to the guidance for more details.