Evaluation of Bioequivalence of Drug Products
Position Statement of the International Association for Pharmaceutical Technology (APV e. V.) on the Draft Guideline on the Investigation of Bioequivalence by the Committee for Medicinal Products for Human Use (CHMP)
In July 2008 the Committee for Medicinal Products for Human Use (CHMP) has issued a Draft “Guideline on the Investigation of Bioequivalence” which has been adopted by CHMP for release for consultation on July 24, 2008. This guideline will replace the “Note for guidance on the investigation of bioavailability and bioequivalence” (CPMP/EWP/QWP/1401/98) and the related questions in the Q&A document (EMEA/CHMP/EWP/40326/2006). The new guideline also includes recommendations on biowaivers based on the Biopharmaceutic Classification System (BCS).
pharmind 2009, Nr. 2, Seite 258