The AAPS journalHumansUnited StatesTherapeutic EquivalencyUnited States Food and Drug AdministrationRivaroxaban
Reanalysis of Plasma Samples Collected from a CRO Reveals Possible Patterns of Bioanalytical Misconduct.
Jinhui Zhang, Charles Bonapace, Arindam Dasgupta, Brian J Folian, Sean Y Kassim, Patrick J Faustino
Published: 202510.1208/s12248-025-01163-1
Abstract
Data integrity is necessary to help ensure the accuracy, consistency, validity and completeness of data. Data can be untraceably manipulated when it lacks adequate integrity. The FDA identified data integrity concerns with the pharmacokinetic data of…
Preview only. Read the full abstract at the source