Bioequivalence and Bioavailability Forum • FDA’s RSABE code (lenghty!)

FDA’s RSABE code (lenghty!) [RSABE / ABEL]

posted by Helmut – Vienna, Austria, 2013-01-14 22:40 (4897 d 01:17 ago) – Posting: # 9839
Views: 8,893

Hi John,

❝ ❝ From the above parameters, calculate the final 95% upper confidence bound:

❝ ❝ theta=((log(1.25))/0.25)**2;

❝

❝ From the progesterone FDA guidance Dec 2012. I see different equation for theta:

❝

❝ theta=((log(1.11111))/0.1)**2;

❝

❝ Yours is wrong?

Nope. Maybe you had the warfarin-guidance also open in your reader. :-D

Yours would mean downscaling. In the Dec 2012 revision FDA corrected only the ‘visibility’ (missing lines which were formatted in white on a white background). The formula I gave is still the same (upscaling) like in previous versions. See p.6 for the partial replicate and p.8 for the full replicate.

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Complete thread:

FDA’s RSABE code (lenghty!) Helmut 2012-01-03 03:27 [RSABE / ABEL]
- FDA’s RSABE code (lenghty!) jag009 2013-01-14 19:47
  - FDA’s RSABE code (lenghty!)Helmut 2013-01-14 21:40