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95% Upper bound calculation [RSABE / ABEL]

posted by GM - India, 2018-03-13 05:09  - Posting: # 18525
Views: 832

Hi Katrin,

» actually the FDA draft guidance on acyclovir cream recommends the use of the RSABE approach as stated in the Progesterone Guidance.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the analysis in order to derive the upper bound of this CI is to use an approach similar to that described in the FDA Draft Guidance on Progesterone (recommended Apr 2010; revised Feb 2011), with appropriate modifications for this replicate experimental design.


Thanks for the reply. I understand this in the same way.

But my question is, as per progesterone guideance the RSABE calculation is rightway to do for IVPT..?
Because, we are not using Test and Reference formulations on the same cell (like healthy volunteers in PK) :confused:.

If YES, what are that necessary changes you suggest?

Kindly help me in this regards.

Thank you in advance.

Regards,
GM

Best Regards,
GM

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