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RegisterBE Information Request [Regulatives / Guidelines]
Request
If there is a difference in content of the active substance more than 5% and i will include this difference in content for the calculation of geometric mean and confidence interval of main pk parameters according to canadian guidelines 1992, can you give me your opinion about this application if true or not, if true can you refer to another guidelines apply this concept and the requirements for application.
very thanks
Amr hussein
Edit: Category changed. [Jaime]
If there is a difference in content of the active substance more than 5% and i will include this difference in content for the calculation of geometric mean and confidence interval of main pk parameters according to canadian guidelines 1992, can you give me your opinion about this application if true or not, if true can you refer to another guidelines apply this concept and the requirements for application.
very thanks
Amr hussein
Edit: Category changed. [Jaime]
Complete thread:
- BE Information RequestA-M-R 2011-01-23 08:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Potency correction Jaime_R 2011-01-23 14:44
- The unknown EMA d_labes 2011-01-24 08:19
- The unknown EMA Jaime_R 2011-01-24 10:52
- The unknown EMA ElMaestro 2011-01-24 13:22
- The unknown EMA d_labes 2011-01-24 08:19
- Potency correction Jaime_R 2011-01-23 14:44
Ing. Helmut Schütz