qPCR is a molecular technique that can be used to detect analytes for many different bioanalytical measurements to support drug development. The emergence of new modalities such as gene, cell, and RNA therapies has increased the need for regulated bioanalytical qPCR assays to support the measurement of safety and efficacy in preclinical and clinical studies. While there are references in the literature to certain requirements for qPCR assays, there is an absence of regulatory guidance on their validation. Given the vast usage of qPCR in bioanalysis, there is an outstanding need to understand the proper application of regulatory requirements as it pertains to the context of use for a particular assay. With the lack of specific guidance in every scenario, it is easy to overinterpret assay requirements for qPCR without added value to the drug development program. In this presentation, I will focus on the current and common regulatory guidance documents that are referenced for qPCR and case studies to highlight examples of how different qPCR assays with different purposes can be characterized in validation.
Learning Objectives:
Upon completion, participants will be able to understand the regulatory landscape associated with molecular assays used in drug development.
Upon completion, participants will be able to learn about context of use and how to best validate a molecular assay based on its intended purpose.
Upon completion, participants will be able to apply these concepts to their drug programs with lessons learned and case study examples.
