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RegisterAripiprazole Bioequivalence Query [Regulatives / Guidelines]
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]
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]
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Shankaranarayanan
Shankaranarayanan
Complete thread:
- Aripiprazole shankar 2013-12-13 08:00
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Aripiprazole Bioequivalence Queryshankar 2013-12-16 05:35
- Two RLDs Helmut 2013-12-16 15:29
- Aripiprazole Bioequivalence Queryshankar 2013-12-16 05:35
Ing. Helmut Schütz