Bioequivalence and Bioavailability Forum

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

posted by Helmut  – Vienna, Austria, 2021-12-06 11:55 (1664 d 06:01 ago) – Posting: # 22688
Views: 4,621

Hi,

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• In the Draft Guidance on Warfarin Sodium (December 2012).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• In APPENDIX C of the Draft Guidance Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Sub­mitted Under an ANDA (August 2021).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

• FDA: SAS-code for NTIDs Bebac user 2021-12-06 00:36 
  • FDA: SAS-code for NTIDsHelmut 2021-12-06 10:55