In vitro release testing is an alternative to bioequivalence studies and can save both time and cost in pharmaceutical formulation development and post approval quality control. Updates to the U.S. Pharmacopeia provide guidance for in vitro testing of semi-solid dosage forms. This change in regulatory perspective will likely result in regulatory requests for in vitro test results. Are you ready?
Read our white paper to learn more about in vitro release testing for semi-solid topical dosage forms, the changing regulatory landscape, and how to navigate through the process.