Bioequivalence and Bioavailability Forum

FDA BE Guide Warfarin – never used? [Regulatives / Guidelines]

posted by Helmut  – Vienna, Austria, 2017-07-13 18:53 (2475 d 22:35 ago) – Posting: # 17538
Views: 5,579

Hi nobody,

❝ […] a list of other FDA individual BE guides on hand referring to the methods specified in the warfarin guideline? (Google didn't find anything for me...).

 ⇐ click!

Not a list but have a look at tacrolimus, sirolimus, levothyroxine, valproic acid, carbamazepine, and two other anticoagulants, rivaroxaban and dabigatran.
For dabigatran I expect never ever a “level 3 change” or any generic, since this stuff is highly variable. THX to Boeh­ringer to have this crap on the market.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• FDA BE Guide Warfarin – never used? nobody 2017-07-13 15:13 [Regulatives / Guidelines] 
  • FDA BE Guide Warfarin – never used?Helmut 2017-07-13 16:53
    • FDA BE Guide Warfarin – never used? nobody 2017-07-13 19:00
      • Sample sizes are not prohibitive Helmut 2017-07-13 19:54
        • Sample sizes are not prohibitive nobody 2017-07-13 20:12
          • Sample sizes are not prohibitive Helmut 2017-07-13 20:36