Bioequivalence and Bioavailability Forum • All samples might be informative

All samples might be informative [Bioanalytics]

posted by Helmut – Vienna, Austria, 2024-06-05 13:33 (398 d 23:51 ago) – Posting: # 24021
Views: 3,542

Hi QA and 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.

I agree.

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

I would not perform two analyses for BE, only report the concentrations of the subject who withdraw consent. See the footnote of this post why in my CRO we analyzed all samples.

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Helmut Schütz

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Complete thread:

Bioanalysis of drop out/ Withdrawal subjects for Health Canada submission shreyas goswami 2024-06-01 11:13
- 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 submission qualityassurance 2024-06-04 05:25
      - All samples might be informativeHelmut 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