GMR not relevant in ABE [Regulatives / Guidelines]
Hi Biostats
See your condition #2 and the guidance
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.
❝ 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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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- bioequivalence criteria for NTID Biostats 2018-03-29 12:39 [Regulatives / Guidelines]
- bioequivalence criteria for NTID Helmut 2018-03-29 14:27
- bioequivalence criteria for NTID Biostats 2018-03-30 06:25
- GMR not relevant in ABEHelmut 2018-03-30 11:19
- Presentation of data in report and SAS output arl_stat 2020-10-15 16:12
- GMR not relevant in ABEHelmut 2018-03-30 11:19
- bioequivalence criteria for NTID Biostats 2018-03-30 06:25
- bioequivalence criteria for NTID jag009 2018-03-29 17:20
- bioequivalence criteria for NTID Helmut 2018-03-29 14:27