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RegisterEMA perspective: Cmax less than 5% for Test Product [Regulatives / Guidelines]
Dear all
A BCS class I substance is characterized by very good solubility and very high bioavailability. So if you have no plasma concentrations you can be pretty shure that the subject did not take the drug. In this case I think it could be possible to argue with the regulatory authority and maybe your assessor is willing to follow your argumentation. It is a chance.
Kind regards
Dan
A BCS class I substance is characterized by very good solubility and very high bioavailability. So if you have no plasma concentrations you can be pretty shure that the subject did not take the drug. In this case I think it could be possible to argue with the regulatory authority and maybe your assessor is willing to follow your argumentation. It is a chance.
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:
- EMEA perspective: Cmax less than 5% for Test Product luvblooms 2013-08-20 07:01
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA perspective: Cmax less than 5% for Test Product d_labes 2013-08-20 08:28
- EMA perspective: Cmax less than 5% for Test Product luvblooms 2013-08-20 10:22
- EMA perspective: Cmax less than 5% for Test ProductDr_Dan 2013-08-20 14:21
- EMA perspective: Cmax less than 5% for Test Product d_labes 2013-08-20 08:28
Ing. Helmut Schütz