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RegisterLansoprazole [Design Issues]
Hi Shankar,
See the FDA Industry Guidance on Statistical Issues in Bioavailability and Bioequivalence Studies. Download from FDA site. There are tables given to find out the number of subjects required in replicate design based on %CV.
drshiv
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Edit: Full quote removed. Please see this post! [HS]
See the FDA Industry Guidance on Statistical Issues in Bioavailability and Bioequivalence Studies. Download from FDA site. There are tables given to find out the number of subjects required in replicate design based on %CV.
drshiv
--
Edit: Full quote removed. Please see this post! [HS]
Complete thread:
- Lansoprazole shankar 2007-06-21 09:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Lansoprazoledrshiv 2007-06-27 10:22
- HVDs Helmut 2007-06-30 14:02
- HVDs shankar 2007-07-04 11:17
- HVDs in the EU :-(( Helmut 2007-07-06 16:34
- HVDs in the EU :-(( drks 2007-07-07 15:53
- Lansoprazole in the UK Helmut 2007-07-08 13:01
- HVDs in the EU :-(( drks 2007-07-07 15:53
- HVDs in the EU :-(( Helmut 2007-07-06 16:34
- HVDs shankar 2007-07-04 11:17
Ing. Helmut Schütz