NORTHERN BIO BLOG: WEBINARS

Triplex RT-dPCR Method for a Safety Study in Drug Development

Gene expression analysis is typically completed for various safety and efficacy studies to complement drug development for viral and non-viral vector therapeutics. Currently, there is no definitive guidance for this type of bioanalysis; rather, various contract research organizations design an internal set of acceptance criteria to develop and qualify or validate assays to be used for downstream sample analysis. Method Qualification information will outline specific acceptance criteria, with supporting data, to demonstrate that a robust assay has been created for downstream sample analysis.