Unknown x corrected? [RSABE / ABEL]

posted by Qilex Homepage – France, 2016-09-21 14:25 (3062 d 03:21 ago) – Posting: # 16656
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Hi Detlew

❝ But I'm not quite sure if this applies in our context.

❝ What makes me curious about this is that in the various papers about scaled ABE and also about Individual BE (where (µTR)2 is also part of the IBE criterion) there is not any hint of such a 'correction'.

:ponder:.


Any update on the "corrected" x value? The two Lászlós presented a method to "calculate the confidence limits of the reference-scaled SABE by modifying the method of Hyslop et al". The latter method "utilizes Howe's approximation I". The FDA draft guidance on progesterone states that "the method of obtaining the upper confidence bound is based on Howe’s Approximation I".

  1. Hyslop T, Hsuan F, Holder DJ. A small sample confidence interval approach to assess individual bioequivalence. Stat Med 2000;19(20):2885–2897.
  2. Tothfalusi L, Endrenyi L, Arieta AG. Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence. Clin Pharmacokinet 2009;48(11):725–743.
  3. Tothfalusi L, Endrenyi L, Midha KK, et al. Evaluation of the bioequivalence of highly-variable drugs and drug products. Pharm Res 2001;18(6):728–733.

Philippe

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