At the start of October the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “The Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls.” This guidance provides general recommendations regarding the development, evaluation, and use of physiologically based pharmacokinetic (PBPK) analyses which has been used to aid the biopharmaceutical development of oral drug products. The guidance covers how to develop, evaluate, and apply PBPK models for biopharmaceutics-related uses, such as establishing clinically relevant dissolution specifications and quality risk assessment for post-approval manufacturing changes.
This guidance document sits alongside previously issued FDA guidance on the use of PBPK in drug development. In 2018 the FDA published guidance detailing the format and content requirements for any submitted PBPK modelling. These guidances demonstrate the growing importance, in drug development, of this mechanistic modelling methodology. Moreover, PBPK modelling is fast becoming an essential tool in the robust evaluation of potential new drugs.