Revalidation (ULOQ, carryover) [Bioanalytics]

posted by Ohlbe – France, 2009-12-20 00:52 (6030 d 06:41 ago) – Posting: # 4512
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Dear Debbie and VP,

❝ i am wondering what partal validation you have performed?

❝ since when you have extended the calibration range, you should perform the

❝ complete validation.


Well... As I heard in a recent presentation, if you want to call it a partial validation because you won't study stock solution stability again :-D Why not ? And selectivity is already done too.

But indeed you have to go back to linearity, within and between run precision and accuracy, stability experiments, etc.

Regards
Ohlbe

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