Homework [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2014-11-07 16:31 (4249 d 04:52 ago) – Posting: # 13841
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Hi Tina,

please do your homework first (see this post). Hints: ICH’s E5(R1), the associated Q&A-document, and guidelines adopted by the FDA and EMA.

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