Bioequivalence and Bioavailability Forum • Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission

Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission [Bioanalytics]

posted by qualityassurance – 2024-06-04 07:25 (382 d 11:54 ago) – Posting: # 24019
Views: 3,447

Dear Shreyas,

What your study protocol and SOP says? If it is deviation from your SOP and protocol, file the deviation, take proper CAPA. I think this is suffice.

If final outcome of the study does not change with and without this subject, it does not seems any risk.

Regards,
QA

Complete thread:

Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission shreyas goswami 2024-06-01 11:13 [Bioanalytics]
- Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission Ohlbe 2024-06-03 09:13
  - Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission shreyas goswami 2024-06-03 17:15
    - Bioanalysis of drop out/ Withdrawal subjects for Health Canada submissionqualityassurance 2024-06-04 05:25
      - All samples might be informative Helmut 2024-06-05 11:33
    - Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission Ohlbe 2024-06-04 09:54
      - Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission shreyas goswami 2024-06-06 20:26