GMR not relevant in ABE [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-03-30 11:19 (1552 d 07:43 ago) – Posting: # 18624
Views: 4,702

Hi Biostats

» Is it mandatory to check - point estimate of the Test/Reference geometric mean ratio must fall within 80.00 - 125.00%?

See your condition #2 and the guidance

Every study should pass the scaled average bioequivalence limits and also regular unscaled bioequivalence limits of 80.00–125.00%.

What do you think where the GMR lies if a study passes ABE? It is only nice to know (unless you are concerned about this discussion). If a study fails ABE, the location of the GMR is even less relevant. Hence, the FDA does not ask for it.

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