Phase 6: In-Vitro Drug Release and Biopharmaceutics

Phase 6: In-Vitro Drug Release and Biopharmaceutics contains 4 topic pages in Pharmaceutics.

In-vitro release testing predicts in-vivo drug performance, ensures batch-to-batch manufacturing consistency, supports bioequivalence claims, and guides formulation optimisation throughout development. It constitutes a mandatory quality control test for all solid oral dosage forms under USP <711> and is strongly recommended, and increasingly required, for semi-solid and transdermal products through in-vitro release testing methodology. This chapter addresses dissolution testing, in-vitro release testing for topical products, the mathematical modelling of release kinetics, and the biopharmaceutical concepts of in-vitro–in-vivo correlation and bioequivalence that connect laboratory release data to clinical performance.