nobody nothing 2017-07-13 17:13 (2470 d 19:21 ago) Posting: # 17537 Views: 6,076 |
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Hy again! Wanted to have a look on some real-life data re. FDA Warfarin BE Guidance - and found no MA later than 2011 and nothing with PAR published on FDA homepage. Surprise! Does anyone have 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...). Many thanks in advance — Kindest regards, nobody |
Helmut ★★★ Vienna, Austria, 2017-07-13 18:53 (2470 d 17:41 ago) @ nobody Posting: # 17538 Views: 5,565 |
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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 |
nobody nothing 2017-07-13 21:00 (2470 d 15:34 ago) @ Helmut Posting: # 17540 Views: 5,402 |
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Hi Vienna! Thanks a lot for making it googlable for me! Unfortunately even for this broader range of compounds I couldn't find any data at the FDA. Maybe it's tooooo new after all. — Kindest regards, nobody |
Helmut ★★★ Vienna, Austria, 2017-07-13 21:54 (2470 d 14:40 ago) @ nobody Posting: # 17541 Views: 5,530 |
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Hi to the North! ❝ […] Maybe it's tooooo new after all. Maybe. Sample sizes are not that bad. The FDA requires tighter release spec’s. Hence, we implemented 0.975 as the default in PowerTOST .
Now swT∕swR 2.
Boehringer’s formulation change. The family’s slaves planned for T/R 0.85 (tried at lot, couldn’t do better), a CVwR of 80%, and RSABE (old guidance). That’s the infamous 4-period full replicate study in 180 subjects on ClinicalTrials.gov. Nowadays:
— 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 |
nobody nothing 2017-07-13 22:12 (2470 d 14:23 ago) @ Helmut Posting: # 17542 Views: 5,422 |
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❝ ...planned for T/R 0.85 (tried at lot, couldn’t do better), a CVwR of 80%,... Picked from the PAR? — Kindest regards, nobody |
Helmut ★★★ Vienna, Austria, 2017-07-13 22:36 (2470 d 13:58 ago) @ nobody Posting: # 17544 Views: 5,451 |
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Hi nobody, ❝ ...planned for T/R 0.85 (tried at lot, couldn’t do better), a CVwR of 80%,... ❝ ❝ Picked from the PAR? No. Heard from the poor guy who planned the study. — 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 |