Bioequivalence and Bioavailability Forum • Global calculations of CC and QC in the During study report

Global calculations of CC and QC in the During study report [Bioanalytics]

posted by pmgjoshi – India, 2009-03-30 13:12 (6299 d 06:41 ago) – Posting: # 3413
Views: 4,030

Dear all,
It's regarding the During Study Validation Report.
In that we have to take all the CC and QCs for global calculations (calculating Average, SD, RSD etc.for all the CC and QCs acquired during Subject sample analysis).

Case 1. Suppose one of my batches failed for, QCs not meeting the acceptance criteria i.e. 7 out of 12 QCs failed.

(I have put all the QCs value in the excel spreadsheet)

Should the failing QCs be Asterisked (bear '*' and gets excluded from the calculations) and rest of the QCs be considered for Global calulations? Or the failing batch should not be considered?

Case 2. One of my batches meets the acceptance criteria i.e. 3 out of 12 QCs failed. So, should the failing QCs be asterisked and not considered for calculations?

Best regards,
Prashant

Complete thread:

Global calculations of CC and QC in the During study reportpmgjoshi 2009-03-30 11:12
- Global calculations of CC and QC in the During study report Ohlbe 2009-04-03 13:17
  - Global calculations of CC and QC in the During study report pmgjoshi 2009-04-05 16:13