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RegisterValidation of Progesterone [Bioanalytics]
Dear Compliance,
In my opinion the CRO you are dealing with, has followed the right approach by performing the validation with stripped and un-stripped plasma for dealing with the endogenous concentreations of progesterone. Stripping the plasma would remove the drug which is present endogenously. Further only those plasma lots which showed less or nil endogenous level of progesterone were selected for bulk spiking.
As per USFDA's GL on BMV "This guidance provides general recommendations for bioanalytical method validation. The recommendations can be adjusted or modified depending on the specific type of analytical method used." Based on this statement, any approach is acceptable to the regulatory, provided this is scientifically sound.
Regards
P.S.Srinivas
In my opinion the CRO you are dealing with, has followed the right approach by performing the validation with stripped and un-stripped plasma for dealing with the endogenous concentreations of progesterone. Stripping the plasma would remove the drug which is present endogenously. Further only those plasma lots which showed less or nil endogenous level of progesterone were selected for bulk spiking.
As per USFDA's GL on BMV "This guidance provides general recommendations for bioanalytical method validation. The recommendations can be adjusted or modified depending on the specific type of analytical method used." Based on this statement, any approach is acceptable to the regulatory, provided this is scientifically sound.
Regards
P.S.Srinivas
Complete thread:
- Validation of Progesterone Compliance 2013-09-10 10:13
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Validation of Progesteronesarada06884 2013-10-18 08:19
- Validation of Progesterone Compliance 2013-10-19 08:53
- Validation of Progesteronesarada06884 2013-10-18 08:19
Ing. Helmut Schütz