0 évaluation0% ont trouvé ce document utile (0 vote)
144 vues34 pages
The document summarizes discussions from the 3rd European Generic Medicines Association (EGA) Symposium on Bioequivalence that was held in June 2010 in London. Over 160 delegates and representatives from national and EU medicines authorities discussed the revised European Medicines Agency guideline on the investigation of bioequivalence. Key points addressed include clarification on study design issues, an increased ability to waive in vitro tests for highly soluble drugs, rules around data evaluation and acceptance criteria, and questions around implementing the new guideline. The dialogue aimed to improve understanding of the guideline and harmonize its interpretation among regulators and the generic industry.
The document summarizes discussions from the 3rd European Generic Medicines Association (EGA) Symposium on Bioequivalence that was held in June 2010 in London. Over 160 delegates and represe…