Log in
RegisterBioanalytical Method Validation requirement for Kits [Bioanalytics]
Can any body guide me about the requirements of the extent of the bioanalytical method validation experiments required for performing Project sample analysis using commercially available kits. I have read about this in the following reference.
The Broadening Scope of Validation: Towards Best Practices in the World of Bioanalysis, European Bioanalysis Forum, 2nd Annual Open Symposium Hisperia Towers, Barcelona, Spain, 2-4 December 2009
I want to know about the regulatory requirements while validating a method using commercial kits which can further be used during Project Sample Analysis for a clinical study intended for regulatory submission.
Edit: Conference report. [Helmut]
The Broadening Scope of Validation: Towards Best Practices in the World of Bioanalysis, European Bioanalysis Forum, 2nd Annual Open Symposium Hisperia Towers, Barcelona, Spain, 2-4 December 2009
I want to know about the regulatory requirements while validating a method using commercial kits which can further be used during Project Sample Analysis for a clinical study intended for regulatory submission.
Edit: Conference report. [Helmut]
Complete thread:
- Bioanalytical Method Validation requirement for KitsAKV 2010-12-02 06:18
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Business as usual Helmut 2010-12-02 13:35
- Business as usual AKV 2010-12-03 06:27
- Business as usual Helmut 2010-12-02 13:35
Ing. Helmut Schütz