Log in
RegisterReg: Partial method validation [Bioanalytics]
Dear sir,
This is regarding the project that was carried out on instrument API 3000 and after then it has been transferred to API 3200. The calibration range has been changed from 50ng/mL-5000ng/mL to 10ng/mL - 5000ng/mL. After changing the instrument only specificity and one precision & accuracy batch has been submitted. My question is it sufficient to carry out only one P&A batch?
Isn't there need of carry over and more P&A experiment?
Edit: Category changed. [Helmut]
This is regarding the project that was carried out on instrument API 3000 and after then it has been transferred to API 3200. The calibration range has been changed from 50ng/mL-5000ng/mL to 10ng/mL - 5000ng/mL. After changing the instrument only specificity and one precision & accuracy batch has been submitted. My question is it sufficient to carry out only one P&A batch?
Isn't there need of carry over and more P&A experiment?
Edit: Category changed. [Helmut]
Complete thread:
- Reg: Partial method validationshweta 2009-10-08 13:37 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Reg: Partial method validation Ohlbe 2009-10-08 15:50
- Reg: Partial method validation shweta 2009-10-09 11:07
- Reg: Partial method validation moblak 2009-10-13 04:02
- Reg: Partial method validation shweta 2009-10-14 09:46
- Reg: Partial method validation Helmut 2009-10-14 12:44
- Reg: Partial method validation shweta 2009-10-14 09:46
- Reg: Partial method validation Ohlbe 2009-10-08 15:50
Ing. Helmut Schütz