FDA Publishes Draft Guidance on Format and Content of Physiologically-Based Pharmacokinetic Analyses

According to the Background, “This guidance outlines the recommended format and content for a sponsor to submit physiologically based pharmacokinetic (PBPK) analyses to the FDA to support applications including investigational new drug (INDs) applications, new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs). To enable efficient and consistent review, the FDA recommends including the following five sections in a PBPK study report: (1) Executive Summary; (2) Materials and Methods; (3) Results; (4) Discussion; and (5) Appendices.”  See the guidance here or contact us for help designing your BA/BE study.