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RegisterMethod re-validation [Bioanalytics]
Dear all
we are facing a problem. For a study, bio-analytical method is developed & validated.
Due to some modifications it requires a re-validation.
If this re-validation is performed parallel to clinical phase of the study but we complete it before bio-analysis, what will be the regulatory acceptance of this study ?
we are facing a problem. For a study, bio-analytical method is developed & validated.
Due to some modifications it requires a re-validation.
If this re-validation is performed parallel to clinical phase of the study but we complete it before bio-analysis, what will be the regulatory acceptance of this study ?
Complete thread:
- Method re-validationdrplacebo 2008-01-09 12:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Method re-validation Helmut 2008-01-09 12:17
Ing. Helmut Schütz