[Opinion] Should the 90% CI for GMR be required to encompass 1 [RSABE / ABEL]
Hi John,
Thanks for your response. Let me see if I can clear this up.
Kind of. I am saying that a large enough sample size can force a test product with e.g. 89% relative BA (e.g. 100mg/112mg) relative to RLD to pass. The difference between 100 and 112mg is clinically significant for this product. I am wondering if adding the condition I talked about from the beginning would help.
I was using the 100/112/125 example rather than talking about relative F to try to elucidate the clinical scenario, which I am doing a poor job of.
I haven't. Thanks!
Cheers,
BF
Thanks for your response. Let me see if I can clear this up.
❝ Are you trying to say that a large enough sample size can force a 100 mg product and a 112 mg product to become bioequivalent because the BE window has a ± 20% around 100%?
Kind of. I am saying that a large enough sample size can force a test product with e.g. 89% relative BA (e.g. 100mg/112mg) relative to RLD to pass. The difference between 100 and 112mg is clinically significant for this product. I am wondering if adding the condition I talked about from the beginning would help.
I was using the 100/112/125 example rather than talking about relative F to try to elucidate the clinical scenario, which I am doing a poor job of.
❝ Please don't forget that there is a criteria on T/R total assay/potency to be within 5%. Your 110mg and 112 mg has >5% potency and that alone invalidates your example.
I haven't. Thanks!
Cheers,
BF
Complete thread:
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 18:43 [RSABE / ABEL]
- [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 19:07
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- [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 23:03
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 23:57
- Black Swan again mittyri 2018-04-05 17:57
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 23:57
- [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 23:03
- [Opinion] Should the 90% CI for GMR be required to encompass 1bebac_fan 2018-03-28 21:59
- [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-28 21:25
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 20:05
- [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 19:44
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 19:23
- [Opinion] Should the 90% CI for GMR be required to encompass 1 Helmut 2018-03-28 23:57
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 13:46
- [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 16:52
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 16:57
- [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 19:55
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 20:30
- [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 21:22
- Paper & Presentations Helmut 2018-03-30 01:33
- Donald Schuirmann’s opinion Helmut 2018-04-10 14:41
- [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 21:22
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 20:30
- [Opinion] Should the 90% CI for GMR be required to encompass 1 jag009 2018-03-29 19:55
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-29 16:57
- [Opinion] Should the 90% CI for GMR be required to encompass 1 ElMaestro 2018-03-28 19:07