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RegisterValidation of Progesterone [Bioanalytics]
Dear All,
We are working on Progesterone and I have query related to the approach applied by the CRO while validating the method.
As per my understanding and methods from the various CRO, all have done the validation with stripped and un-stripped plasma for the endogenous molecule. However the CRO with whom we are dealing has validated the method by using female plasma and use only those plasma for the bulk spiking which has shown less or nil endogenous level of progesterone and done the validation as per routine practices/ process applied to routine molecule.
Is this approach is acceptable? however during study we are going to collect 2-3 pre dose sample for the base line correction.
The approach applied by the CRO is new for me and seeking your expert comment on this. Logically I am agree with their approach however only worried about how the regulatory take this.
Regards,
Compliance
We are working on Progesterone and I have query related to the approach applied by the CRO while validating the method.
As per my understanding and methods from the various CRO, all have done the validation with stripped and un-stripped plasma for the endogenous molecule. However the CRO with whom we are dealing has validated the method by using female plasma and use only those plasma for the bulk spiking which has shown less or nil endogenous level of progesterone and done the validation as per routine practices/ process applied to routine molecule.
Is this approach is acceptable? however during study we are going to collect 2-3 pre dose sample for the base line correction.
The approach applied by the CRO is new for me and seeking your expert comment on this. Logically I am agree with their approach however only worried about how the regulatory take this.
Regards,
Compliance
Complete thread:
- Validation of ProgesteroneCompliance 2013-09-10 10:13
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Validation of Progesterone sarada06884 2013-10-18 08:19
- Validation of Progesterone Compliance 2013-10-19 08:53
- Validation of Progesterone sarada06884 2013-10-18 08:19
Ing. Helmut Schütz