Bioequivalence and Bioavailability Forum • FDA: crystal ball

FDA: crystal ball [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2015-12-29 16:43 (3335 d 17:32 ago) – Posting: # 15775
Views: 9,626

Hi Mahesh,

❝ ❝ #2 is strange. Where would one get the X and Y from?

❝

❝ Can we use our pilot study data (CV % for partial AUC from pilot study) to support truncated design in pivotal study.

Which partial AUC do you have in mind? Especially demonstrating low variability in distribution gives me headaches. Sanofi didn’t have the balls to come up with values of cut-off variabilities (plural!). Why the heck did they state <X% for low and ≥Y% for high CV? What’s in between? Case-by-case, pick out the best? The FDA is concerned only about high variability and I guess they mean a CV_w of 30%.

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Helmut Schütz

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Complete thread:

truncated design Mahesh M 2015-12-29 11:21 [Regulatives / Guidelines]
- FDA: AUC0–72 Helmut 2015-12-29 13:12
  - FDA: AUC0–72 Mahesh M 2015-12-29 13:51
    - FDA: crystal ballHelmut 2015-12-29 15:43
      - FDA: crystal ball Averroes 2016-05-27 00:01