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The method presented is used by pharmaceutical regulatory authorities to detect data manipulation in clinical trials (bioequivalence). The code shown makes it possible to use the PK data of a clinical study to determine which blood samples may have been illegally reanalysed in order to positively influence the result of the study.

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FriedrichLoeffler/Detection-of-data-manipulation-in-bioequivalence-trials

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Detection of data manipulation in bioequivalence trials (SaToWIB*)

Here you can find the code for the "SaToWIB routine", based on the idea presented in Anders Fuglsang's publication "Detection of data manipulation in bioequivalence trials". The code is written in R.

Reference:
*Fuglsang A. Detection of data manipulation in bioequivalence trials. Eur J Pharm Sci. 2021 Jan 1;156:105595. doi: 10.1016/j.ejps.2020.105595. Epub 2020 Oct 11. PMID: 33053409.

How to proceed

  1. Read Instructions and explanations.pdf
  2. Download or copy SaToWIB.R in your R terminal (maybe you first need to install R and Rstudio)
  3. Create a new folder on your device and download formatted PK data, which is an example of study data and will be used by the program.
  4. Copy the path of the new folder (which contains the formatted PK data) and enter the path three times in the SaToWIB code as described in chapter 1 of the code.
  5. Run the code
  6. You might need to run chapter 7 "EXPORT PLOTS TO pdf" of the code step by step (Ctrl+Enter) if you cannot open the Similarity plasma sample plots.pdf in your new folder.
  7. The results Similarity plasma sample results.csv and Similarity plasma sample plots.pdf are created in the new folder. As an example of the results please find both files here as well.
  8. Please do not hesitate to comment or create issues to improve and expand this article on safe medicines!

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The method presented is used by pharmaceutical regulatory authorities to detect data manipulation in clinical trials (bioequivalence). The code shown makes it possible to use the PK data of a clinical study to determine which blood samples may have been illegally reanalysed in order to positively influence the result of the study.

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