Summary of Biopharmaceutics

The section (module 2.7.1) of a CTD providing a summary of the drug formulation development process, including: the in vitro and in vivo dosage form performance, as well as the general approach and rationale used in developing the bioavailability (BA), comparative BA, bioequivalence (BE), and in vitro dissolution profile database. The sumary is intended to provide the reviewer with an overview of the analytical methods used, and the performance characteristics of assay validation (e.g., linearity range, sensitivity, specificity) and quality control (e.g., accuracy and precision).