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Toxicology Review Food and Drug Administration Fda  Form

Toxicology Review Food and Drug Administration Fda Form

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good afternoon and thank you to all of the organizers of this workshop for allowing me to present on this important topic today so let's get right to it let's quickly go over the learning objectives for this talk the first thing i'll discuss is what the office of study integrity and surveillance does in terms of analytical inspections and how we go about identifying potential data integrity issues then i'll discuss some examples of data that while not absolutely indicative of a data integrity issue are red flags these are also examples that should allow you as those who are generating and reviewing data to know what to be aware of within your facility and operations some of the examples we'll discuss include pk and concentration data anomalies and bioequivalence studies outliers and failures in precision and accuracy assessments chromatography pitfalls and software security and audit trails osis is tasked with verifying the reliability and integr

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