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shankar ★ India, 2013-12-13 09:00 (4576 d 15:18 ago) Posting: # 12052 Views: 5,350 |
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Dear Helmut, Please let me know why FDA guidance for Aripiprazole bioequivalence study recommending Fasting and fed study for 10 mg and fasting study for 5 mg? The strength available is 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg and the literature indicates Aripiprazole having liner pharmacokinetics. If the drug has linear kinetics why BE study conducted for 5 mg also? Regards, Shankar — Shankaranarayanan |
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shankar ★ India, 2013-12-16 06:35 (4573 d 17:43 ago) @ shankar Posting: # 12060 Views: 5,107 |
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Dear Helmut, Please let me know why FDA guidance for Aripiprazole bioequivalence study recommending Fasting and fed study for 10 mg and fasting study for 5 mg? The strength available is 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg and the literature indicates Aripiprazole having liner pharmacokinetics. If the drug has linear kinetics why BE study conducted for 5 mg also? Regards, Shankar Edit: Moved to a previous post. [Helmut] — Shankaranarayanan |
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Helmut ★★★   Vienna, Austria, 2013-12-16 16:29 (4573 d 07:49 ago) @ shankar Posting: # 12064 Views: 4,689 |
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Dear Shankar, ❝ Dear Helmut, ▲ Not interested in other opinions? Top-level posts please to the entire group. Please see the Forum’s Policy. ❝ Please let me know why FDA guidance for Aripiprazole bioequivalence study recommending Fasting and fed study for 10 mg and fasting study for 5 mg? Both 5 and 10 mg strengths are RLDs (Orange Book). Maybe they differ slightly in their indications? Do your homework first. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz