Bebac user

2021-12-06 00:36
(205 d 17:31 ago)

Posting: # 22687
Views: 923

 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]
Vienna, Austria,
2021-12-06 10:55
(205 d 07:12 ago)

@ Bebac user
Posting: # 22688
Views: 775

 FDA: SAS-code for NTIDs


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  • In the Draft Guidance on Warfarin Sodium (December 2012).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  • In APPENDIX C of the Draft Guidance Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Sub­mitted Under an ANDA (August 2021).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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
UA Flag
 Admin contact
22,181 posts in 4,647 threads, 1,572 registered users;
online 4 (0 registered, 4 guests [including 2 identified bots]).
Forum time: Wednesday 19:07 CEST (Europe/Vienna)

Nerds don’t just happen to dress informally.
They do it too consistently.
Consciously or not, they dress informally
as a prophylactic measure against stupidity.    Paul Graham

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz