Change in ULOQ concentration [Bioanalytics]

posted by auditor – India, 2012-02-03 09:28 (5261 d 18:02 ago) – Posting: # 8048
Views: 1,990

Dear All,

In one of the validation it is observed that the ULOQ is decreased from 3000 pg/ml to 500 pg/ml. To justify this only one P&A is injected. I feel to justify this recovery and DI need to be perform again as QC level is also change accordingly.

Kindly give you suggestion on this.

Regards,

Auditor

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