Reg: Partial method validation [Bioanalytics]

posted by moblak – 2009-10-13 06:02 (6105 d 13:41 ago) – Posting: # 4345
Views: 5,820

Dear Shweta

❝ The calibration range has been changed from 50ng/mL-5000ng/mL to 10ng/mL - 5000ng/mL.

❝ Isn't there need of carry over and more P&A experiment?


IMHO you should also perform all stability experiments at the new (lower) QCL level.

Regards
Marko

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