Evaluation of Incurred Subject Period Re-analysis (ISPR) as a Tool to Distinguish Fraudulent Pharmacokinetic Profile Pairs from Non-fraudulent Pairs

• Published in: The AAPS journal Vol. 27; no. 1; p. 15
• Main Authors: Fuglsang, Anders, Dogra, Anshul, Sharma, Naveen
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 16.12.2024; Springer
• Subjects: Algorithms; Biochemistry; Biomedical and Life Sciences; Biomedicine; Biotechnology; Fraud; Fraud - prevention & control; Humans; Pharmacokinetics; Pharmacology/Toxicology; Pharmacy; Research Article; Therapeutic Equivalency; Bioequivalence; Data integrity; Re-analysis; Pharmacokinetics

Duplicate pharmacokinetic profiles in bioequivalence trials is an issue which has caused hundreds of retracted marketing authorizations. No formal test for profile duplication exists in spite of the existence of profile comparison algorithms, so defining a threshold that distinguishes a naturally oc...