FDA finalizes guidance on physiologically based pharmacokinetic analyses

On August 31, FDA published a notice in the Federal Register that said the 2016 draft guidance on the recommended format and content for physiologically based pharmacokinetic (PBPK) analyses has been finalized.

On August 31, FDA published a notice in the Federal Register that said the 2016 draft guidance on the recommended format and content for physiologically based pharmacokinetic (PBPK) analyses has been finalized. The notice said the revisions, which have not yet been made public, took into consideration at least some of the issues raised during the comment period. For instance, the European Medicines Agency (EMA) suggested adding the objective of a PBPK analysis, assuming that reports "will be the same to the two agencies and therefore that it could be of value to have a more harmonized view of what to include." The EMA also made suggestions related to how FDA plans to handle "sensitivity analysis of multiple components," and specifying methodological approaches for model verification as well as how model results should be confirmed by sponsors.