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RegisterPre dose concentration [Regulatives / Guidelines]
Dear Mr.Auditor,
As per FDA's Individual Product Bioequivalence Recommendation for Ergocalciferol, an endogenous substance, any subject with pre-dose concentration more than 5% of their Cmax should be excluded from BE statistical analysis.
As per FDA's Individual Product Bioequivalence Recommendation for Ergocalciferol, an endogenous substance, any subject with pre-dose concentration more than 5% of their Cmax should be excluded from BE statistical analysis.
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn
Complete thread:
- Pre dose concentration auditor 2012-02-28 08:59 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Pre dose concentrationdrgunasakaran1 2012-02-28 11:36
- Read, Search ... d_labes 2012-02-28 12:03
- Read, Search ... auditor 2012-02-28 12:08
- Sorry d_labes 2012-02-28 12:49
- Read, Search ... Helmut 2012-02-28 14:09
- 5% Cmax rule and endogenous drugs - EMA d_labes 2012-02-28 16:40
- My interpretation + (lenghty) example Helmut 2012-02-28 17:18
- Well done! d_labes 2012-02-29 08:33
- Bad experiences… Helmut 2012-02-29 14:19
- Well done! d_labes 2012-02-29 08:33
- My interpretation + (lenghty) example Helmut 2012-02-28 17:18
- 5% Cmax rule and endogenous drugs - EMA d_labes 2012-02-28 16:40
- Read, Search ... auditor 2012-02-28 12:08
Ing. Helmut Schütz