Trend analysis as per recent USFDA guideline [Bioanalytics]

posted by dshah – India/ United Kingdom, 2020-08-01 07:32 (448 d 02:39 ago) – Posting: # 21815
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Dear All!

If we consider the recent FDA guideline or ICH M10, i believe trend analysis for IS response, CC and QCs is also required. FDA does ask if there is upward or downward trend observed. The important point for SOP of CRO should be - allowed limit for IS response. If this not limited for that 3 subjects, then i believe CRO's practice and SOP needs to be revised.

Regards,
Dshah


Edit: Guidelines linked. [Helmut]

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