Detection of data manipulation in bioequivalence trials

In recent years regulators have documented how pharmaceutical companies or clinical research organisation can manipulate bioequivalence trial data for non-approvable formulations by performing an interim analysis followed by re-analysis of pharmacokinetic profiles under new subject aliases, with a s...

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Bibliographic Details

Published in:	European journal of pharmaceutical sciences Vol. 156; p. 105595
Main Author:	Fuglsang, Anders
Format:	Journal Article
Language:	English
Published:	Elsevier B.V 01.01.2021
Subjects:	Bioequivalence Fraud Re-analysis Residuals Similarity Fraud Bioequivalence Similarity Re-analysis Residuals
ISSN:	0928-0987, 1879-0720, 1879-0720
Online Access:	Get full text
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