GMR not relevant in ABE [Regulatives / Guidelines]
❝ 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.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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- bioequivalence criteria for NTID Biostats 2018-03-29 12:39 [Regulatives / Guidelines]