Bioequivalence and Bioavailability Forum

[Opinion] Should the 90% CI for GMR be required to encompass 1 [RSABE / ABEL]

posted by bebac_fan – US, 2018-03-28 21:23 (2212 d 17:07 ago) – Posting: # 18603
Views: 10,064

Dear ElMaestro,

Thank you for your input. I agree that this rule would punish sponsors have high sample sizes.

I understand this is also a potential mechanism of abuse to get poor drugs approved: Sponsors may increase sample sizes arbitrarily to meet BE. Would my proposed approach prevent that?

Lets take a drug that comes in 100, 112, and 125. Theoretically, a sponsor could get 100, 112, AND 125 dosage forms (assuming CMC doesn't catch it) approved for 112 if they use sample sizes big enough This is my biggest concern.

Thanks again for your input -
bebac_fan

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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:

• [Opinion] Should the 90% CI for GMR be required to encompass 1 bebac_fan 2018-03-28 18:43 
  • [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 1bebac_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 1 jag009 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 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