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RegisterHVDs in the EU :-(( [Design Issues]
Dear Helmut,
I would agree with Shankar in this regard. There are studies with such high variability (70-80%) observed with lansoprazole. We have observed similar variability for lansoprazole, particularly with fed studies. In fact, for various studies submitted to MHRA, the confidence interval has been widened on the basis of high variability. One can find different approvals with studies showing such high variability at the MHRA site upon searching for lansoprazole.
❝ Where did you get your CV% from? Even for lansoprazole >50% is rather high!
❝ There are studies published with a CV% of 30-40 for Cmax. 
I would agree with Shankar in this regard. There are studies with such high variability (70-80%) observed with lansoprazole. We have observed similar variability for lansoprazole, particularly with fed studies. In fact, for various studies submitted to MHRA, the confidence interval has been widened on the basis of high variability. One can find different approvals with studies showing such high variability at the MHRA site upon searching for lansoprazole.
Complete thread:
- Lansoprazole shankar 2007-06-21 09:39
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Lansoprazole drshiv 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