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Egypt,
2021-12-06 01:36
(1312 d 09:49 ago)

Posting: # 22687
Views: 4,190
 

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

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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 11:55
(1311 d 23:30 ago)

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Posting: # 22688
Views: 3,433
 

 FDA: SAS-code for NTIDs

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  • In the Draft Guidance on Warfarin Sodium (December 2012).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  • In APPENDIX C of the Draft Guidance Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Sub­mitted Under an ANDA (August 2021).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