Predose study samples [Bioanalytics]

posted by Reddy – 2009-01-16 19:03 (6371 d 05:57 ago) – Posting: # 3049
Views: 4,058

Hi,

Is there any acceptance criteria for the interference of drug and IS in predose study sample? What is the exact acceptance criteria to accept a predose sample (without drug and IS) and predose sample (with IS)? Please give me the reference guidelines.

Thanks,
Reddy.

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