Bioequivalence and Bioavailability Forum

Failed AUC 0-t [Study Assessment]

posted by Helmut – Vienna, Austria, 2013-08-29 15:58 (4681 d 15:59 ago) – Posting: # 11379
Views: 11,159

Hi Tina,

❝ 1. If it were to be a product issue, would not both parameters be affected?

Not necessarily.

❝ 2. What are the causes for having only failing AUC 0-t?

Likely better absorption. But a pilot study does not “fail” anyway.

❝ 3. Would increasing sample size (based on variability) to 28 be sufficient to counter the ISV of AUC 0-t?

No – unless you opt for a crazy sample size of 126 subjects (T/R 116%, CV 24%, 80% power). 126 is only applicable if you expect to exactly repeat the T/R and CV in a pivotal study – which is not a good idea. If you use the upper confidence limit of the CV (33.7%) you would need 240 subjects…

I would reformulate. BTW, what was the ratio for C_max?

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Complete thread:

Failed AUC 0-t Tina 2013-08-29 09:25
- Failed AUC 0-t Dr_Dan 2013-08-29 11:04
  - Failed AUC 0-t Tina 2013-08-29 13:11
  - bear for replicates Helmut 2013-08-29 14:33
- Failed AUC 0-tHelmut 2013-08-29 13:58
  - Failed AUC 0-t Tina 2013-08-29 17:48
    - Correct numbers? Helmut 2013-08-29 18:24
- Failed AUC 0-t luvblooms 2013-08-30 09:23

Failed AUC 0-t [Study As­sess­ment]

Complete thread:

Failed AUC 0-t [Study Assessment]