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

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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.

quality-assurance buster fraud bioequivalence clinical-trial re-analysis generic-drugs satowib pk-data
  • Updated Dec 2, 2024
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