Bioequivalence database [Tips / Tricks]

posted by Helmut Homepage – Vienna, Austria, 2007-10-19 16:02 (6412 d 17:48 ago) – Posting: # 1226
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Dear Manoj!

❝ … is there any database of bioequivalence studies conducted in different countries till now other than published literature where one can get the basic design and analytical parameters of any formulation bioequivalence.


Oh, we all want to have that one… :cool:
You my get filed applications under the 'Freedom of Information Act' from the FDA, or search UK's MHRA.
If you are lucky, intra-subject CVs are included; but you may calculate them from the confidence interval as well. Details of the analytical method(s) are always ██████████.
Recommendations for (some) individual products are also available from the FDA.

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