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Q&A published 14 March 2011 [BE/BA News]

posted by Helmut Homepage - Vienna, Austria, 2011-03-16 13:44  - Posting: # 6762
Views: 18,171

Dear all,

the clarification is part of the recent version of the “Questions & Answers: Positions on specific questions addressed to the Pharmacokinetics Working Party” EMA/618604/2000 Rev. 3, dated 26 January 2011, published 14 March 2011.
The interesting part is Section 11. Clarification on the recommended statistical method for the analysis of a bioequivalence study (pages 21–32).

Cheers,
Helmut Schütz
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