Two RLDs [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2013-12-16 16:29 (4573 d 08:03 ago) – Posting: # 12064
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Dear Shankar,

❝ Dear Helmut,

      Not interested in other opinions? Top-level posts please to the entire group.


Please see the Forum’s Policy.

❝ Please let me know why FDA guidance for Aripiprazole bioequivalence study recommending Fasting and fed study for 10 mg and fasting study for 5 mg?


Both 5 and 10 mg strengths are RLDs (Orange Book). Maybe they differ slightly in their indications? Do your homework first.

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