Bioequivalence and Bioavailability Forum • Questions about data manipulation

Questions about data manipulation [GxP / QC / QA]

posted by qualityassurance – 2024-04-30 13:38 (433 d 05:42 ago) – Posting: # 23967
Views: 10,866

Dear Forum members,

❝ Dr. Anders Fuglsang has developed several software programs to detect such manipulation.

Is it advisable that CRO use this software (after implementing the SOP within the system) and prove that no such manipulation was done during BE study. By this way both sponsors and CROs are relaxed and regulatory authority will also have readily available data from the software.
The idea behind above approach is, there is no other way of finding such manipulation (profile duplication) during routine QA review or monitoring by sponsor.

Regards,
QA

Complete thread:

Another one? Helmut 2023-07-19 09:04
- Confirmed Ohlbe 2023-07-21 12:59
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        Questions about data manipulation Ohlbe 2024-05-01 20:58
  - Update Helmut 2024-03-22 20:29
    - Health Canada recalls Helmut 2024-06-09 09:16
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- Another one? Ajay Gupta 2023-07-24 04:19