Evaluation of Bioequivalence of Drug Products / Position Statement of the International Association for Pharmaceutical Technology (APF e. V) on the Draft Guideline on the Investigation of Bioequivalence by the Committee for Medicinal Products for Human Use (CHMP)

Rubrik: europharm

(Treffer aus pharmind, Nr. 02, Seite 258 (2009))

International Association for Pharmaceutical Technology (APV e. V.)

Evaluation of Bioequivalence of Drug Products / Position Statement of the International Association for Pharmaceutical Technology (APF e. V) on the Draft Guideline on the Investigation of Bioequivalence by the Committee for Medicinal Products for Human Use (CHMP) / International Association for Pharmaceutical Technology (APV e. V.)
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). The APV Expert Panel unanimously came to the conclusion that this new guideline represents a significant step forward in the evaluation of bioequivalence of drug products taking into consideration well accepted principles and recent scientific findings in this regulatory document. It was also appreciated that the document focuses solely on bioequivalence and separates these from a general discussion of bioavailability as in the previous Note for Guidance. © ECV- Editio Cantor Verlag (Germany) 2009