Bioequivalence and Bioavailability Forum

❝ Do anybody suggest manual calculation of 95% upper bound in RSABE approach....

❝ Actually I am trying to do this for IVPT study analysis using guidance Acyclovir 5% cream. But here the reference treatment was replicated more than 2 times.

❝ Is it possible to follow the RSABE approach as per the Progesterone Guidance..?

Hello,

actually the FDA draft guidance on acyclovir cream recommends the use of the RSABE approach as stated in the Progesterone Guidance.
See acyclovir cream guidance on page 18:
26. One possible way to perform the analysis in order to derive the upper bound of this CI is to use an approach similar to that described in the FDA Draft Guidance on Progesterone (recommended Apr 2010; revised Feb 2011), with appropriate modifications for this replicate experimental design.


Greetings
Katrin

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Guidance linked. [Helmut]