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RegisterBE demonstrated in pilot study [Regulatives / Guidelines]
Hi
I agree with ElMaestro but before you submit you should check if the test product used in the study is representative of the product to be marketed (see CPMP/QWP/EWP/1401/98 Rev. 1). If you used only a lab scale batch (as in general for pilot studies) you have to perform a pivotal BE study with a validation batch of the test product.
Kind regards
Dan
I agree with ElMaestro but before you submit you should check if the test product used in the study is representative of the product to be marketed (see CPMP/QWP/EWP/1401/98 Rev. 1). If you used only a lab scale batch (as in general for pilot studies) you have to perform a pivotal BE study with a validation batch of the test product.
Kind regards
Dan
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Kind regards and have a nice day
Dr_Dan
Kind regards and have a nice day
Dr_Dan
Complete thread:
- BE demonstrated in pilot study Jana Zigova 2011-04-10 15:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE demonstrated in pilot study ElMaestro 2011-04-10 18:13
- BE demonstrated in pilot studyDr_Dan 2011-04-11 09:56
- BE demonstrated in pilot study ElMaestro 2011-04-10 18:13
Ing. Helmut Schütz