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RegisterElectrochemiluminescence method [Bioanalytics]
Dear Avinash,
For patient follow-up, not for BE trials...
Do your homework: read the draft FDA guidance on bioanalytical method validation, section C, particularly lines 853 to 883. This is just a draft, but I think it provides a good "suggestion".
❝ The method was fully validated by manufacturer.
For patient follow-up, not for BE trials...
❝ Please suggest what would be the additional validation parameters that need to be performed to support the FDA method validation requirement?
Do your homework: read the draft FDA guidance on bioanalytical method validation, section C, particularly lines 853 to 883. This is just a draft, but I think it provides a good "suggestion".
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Electrochemiluminescence method avinash 2014-07-03 06:49
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Electrochemiluminescence methodOhlbe 2014-07-03 12:08
- Electrochemiluminescence method avinash 2014-07-04 11:43
- Electrochemiluminescence methodOhlbe 2014-07-03 12:08
Ing. Helmut Schütz