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RegisterPoint Estimate consideration in sample size estimate [Power / Sample Size]
Dear Helmut,
Thank you very much for your response and kind reminder. I am still interested in the opinions of other experts.
I still have a concern: when using GMR = 1.1 for sample size estimation, the actual GMR is 1.13 and 90% confidence interval is still within the range of 0.8 – 1.25. If the GMR of other generic drugs is within the ±5% difference to the reference, will the FDA approve product marketing? Is there any risk of ANDA’s review? Is it possible to provide examples where GMR is < 0.9 or > 1.1 and the product still be approved by FDA or other regulator?
Best Regards!
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
Thank you very much for your response and kind reminder. I am still interested in the opinions of other experts.
I still have a concern: when using GMR = 1.1 for sample size estimation, the actual GMR is 1.13 and 90% confidence interval is still within the range of 0.8 – 1.25. If the GMR of other generic drugs is within the ±5% difference to the reference, will the FDA approve product marketing? Is there any risk of ANDA’s review? Is it possible to provide examples where GMR is < 0.9 or > 1.1 and the product still be approved by FDA or other regulator?
Best Regards!
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]
Complete thread:
- Point Estimate consideration in sample size estimate kimhuang 2025-10-09 07:21 [Power / Sample Size]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Point Estimate consideration in sample size estimate Helmut 2025-10-14 12:33
- Point Estimate consideration in sample size estimatekimhuang 2025-10-15 00:53
- BE = CI within acceptance range (PE is irrelevant) Helmut 2025-10-15 09:32
- BE = CI within acceptance range (PE is irrelevant) ElMaestro 2025-10-15 10:07
- BE = CI within acceptance range (PE is irrelevant) kimhuang 2025-10-16 09:37
- BE = CI within acceptance range (PE is irrelevant) kimhuang 2025-10-16 08:26
- BE = CI within acceptance range (PE is irrelevant) ElMaestro 2025-10-15 10:07
- BE = CI within acceptance range (PE is irrelevant) Helmut 2025-10-15 09:32
- Point Estimate consideration in sample size estimatekimhuang 2025-10-15 00:53
- Point Estimate consideration in sample size estimate Helmut 2025-10-14 12:33
Ing. Helmut Schütz