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Bioanalytical Method Validation

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 ​

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