Homework [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2013-09-07 16:25 (4679 d 10:32 ago) – Posting: # 11459
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Hi AR_A,

please do your homework first (see this post). Read the countries’ / regions’ relevant guidances / guidelines. Hint:E.g., FDA’s definition:

“Bioequivalence means the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.”


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