Bioequivalence and Bioavailability Forum

Failed AUC 0-t [Study Assessment]

posted by Tina – India, 2013-08-29 11:25 (4272 d 05:33 ago) – Posting: # 11376
Views: 10,260

Dear all,

I have received the results of a pilot study of an IR product.
N=20

90% CI for Cmax is within the BE criteria. However, the upper value of the 90% CI for the AUC 0 to t is 135!. The ISV for AUC 0 to t is 24%.

My questions are:

If it were to be a product issue, would not both parameters be affected?
What are the causes for having only failing AUC 0-t?
Would increasing sample size (based on variability) to 28 be sufficient to counter the ISV of AUC 0-t?

Request guidance on the above study please.

Edit: Category changed. [Helmut]

Complete thread:

Failed AUC 0-tTina 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-t Helmut 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]