Bioanalytical Method Validation
This eLearning module is to understand the Bioanalytical methods and the types of validation, reporting and documentation of validation data
Bioanalytical method validation
Why it matters
Validation of a bioanalytical assay, is to demonstrate that the assay is suitable for its intended purpose.
The results of pivotal nonclinical toxicokinetic, or pharmacokinetic studies. and of clinical trials, including comparative bioavailability or bioequivalence studies, using a validated assay ensures that, you can reliably evaluate the safety and efficacy of drug products.
Finally, well characterized, appropriately validated and documented bioanalytical methods, ensure reliable data to support regulatory approvals.
Who is it for
This module is relevant to all
