Bioequivalence and Bioavailability Forum

Bebac user ☆ Egypt, 2021-12-06 01:36 (864 d 08:38 ago) Posting: # 22687 Views: 2,227	FDA: SAS-code for NTIDs [RSABE / ABEL] Post reply
	I am a beginner sas user, could anyone help me how to apply RSABE for NTIs drugs? And how to calculate variability comparison? Edit: Subject line changed; see also this post #2. [Helmut]

Helmut
★★★

Vienna, Austria,
2021-12-06 11:55
(863 d 22:19 ago)

@ Bebac user
Posting: # 22688
Views: 1,913

FDA: SAS-code for NTIDs

Hi,

the [image]

published SAS-code:

In the Draft Guidance on Warfarin Sodium (December 2012).
Later product-specific guidance refer to this one.
In APPENDIX C of the Draft Guidance Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (August 2021).

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Helmut Schütz

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