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Egypt,
2021-12-06 00:36
(46 d 20:19 ago)

Posting: # 22687
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 FDA: SAS-code for NTIDs [RSABE / ABEL]

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
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Vienna, Austria,
2021-12-06 10:55
(46 d 10:00 ago)

@ Bebac user
Posting: # 22688
Views: 333
 

 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  • In the Draft Guidance on Warfarin Sodium (December 2012).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  • In APPENDIX C of the Draft Guidance Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Sub­mitted Under an ANDA (August 2021).

Dif-tor heh smusma 🖖
Helmut Schütz
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