FDA Announces Availability of the Draft Guidance, “Physiologically Based Pharmacokinetic Analyses-Format and Content”

On December 2, 2016, the U.S. Food and Drug Administration (FDA) announced the availability of the draft guidance entitled “Physiologically Based Pharmacokinetic Analyses — Format and Content.”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 (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), and Abbreviated New Drug Applications (ANDA) to enable efficient and consistent FDA review.  The guidance recommends including the following five sections and their respective content in a PBPK study report:  (1) Executive Summary, (2) Materials and Methods, (3) Results, (4) Discussion, and (5) Appendices.  This guidance does not address methodological considerations and best practices for the conduct of PBPK modeling and simulation, or the appropriateness of PBPK analyses for a particular drug. 

A PBPK analysis uses models and simulations that combine physiology, population, and drug characteristics to describe the pharmacokinetics and/or pharmacodynamics of that particular drug in humans.  Throughout a drug’s life cycle, PBPK analyses can be used to support decisions on whether, when, and how to conduct certain clinical pharmacology studies, inform dosing recommendations, and enable prescription drug labeling.  Currently, the format and content of PBPK analyses that are submitted to FDA vary significantly across drug developers.  Standardizing the content and format of the PBPK analyses can facilitate FDA’s efficient assessment, consistent application, and timely decision making during regulatory review.  This draft guidance aims to facilitate efficient, timely, and consistent FDA review of applications using PBPK.  

You may submit your comments to this guidance by January 31, 2017 to the Docket No. FDA-2016-D-3969 at https://www.regulations.gov.

The “Physiologically Based Pharmacokinetic Analyses — Format and Content” draft guidance is available at http://go.usa.gov/x8U85.  Please refer to the guidance for more details.