Bioequivalence study on Psychotropic drugs [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2012-04-12 11:40 (5173 d 12:56 ago) – Posting: # 8412
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Dear Dr. Deepak C Chilkoti
I guess it is not necessary to have such a license, since a bioequivalence study is an in vivo quality testing taking bioavailability as a surrogate parameter for efficacy. By this a BE study does not reflect the clinical use.
I hope this helps.
Kind regards
Dan

Kind regards and have a nice day
Dr_Dan

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