Predose study samples [Bioanalytics]

posted by babu – India, 2009-02-04 14:57 (6353 d 04:01 ago) – Posting: # 3180
Views: 3,372

Hai reddy,

There is no acceptance criteria for predose samples.
But predose sample also considered as blank matrix. So we have criteria for interference in blank matrix (selectivity) mentioned in FDA guidelines. So same will be applicable for predose sample also. However you should follow as per your predefined inhouse SOPs.

with regards,
Rambabu.S


Edit: Full quote removed. Please see this post! [Helmut]

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