Dissolution methods clinical dosage form

A Clinical Summary is to start with a subsection on Biopharmaceutical Studies, and Associated Analytical and Bioanalytical Chemistry Methods conducted during the clinical development of a drug candidate. The background of the formulation development process is to be briefly provided and is to include information on in vitro and in vivo dosage form performance and the general approach and rationale for developing the bioavailability (BA), comparative BA, bioequivalence (BE), and in vitro dissolution profile database. Also to be included is a summary of the analytical and bioanalytical chemistry methods and the validation characteristics of these methods. 

---