[Opinion] Should the 90% CI for GMR be required to encompass 1 [RSABE / ABEL]
Hi,
I think your clarification above is even more confusing. Your example "T(100mg) vs R(112mg) is bioequivalent with a large enough sample size". 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%? 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.
John
❝ My motivation for the original question: it is conceivable that a one could find T(100mg) and R(112mg) BE with a large enough sample. It is also conceivable that one may find 125mg BE with 112mg. This would cause substantial risk of harm. I thought that perhaps imposing the CI through GMR of 1 limit may prevent this from happening.
I think your clarification above is even more confusing. Your example "T(100mg) vs R(112mg) is bioequivalent with a large enough sample size". 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%? 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.
John
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
- [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 ElMaestro 2018-03-28 19:44
- [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 1jag009 2018-03-28 21:25
- [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 21:59
- [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 1 bebac_fan 2018-03-28 21:59
- [Opinion] Should the 90% CI for GMR be required to encompass 1jag009 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