Free Download Drug Development for Gene Therapy: Translational Biomarkers, Bioanalysis, and Companion Diagnostics
English | 2024 | ISBN: 1119852781 | 496 Pages | PDF, EPUB (True) | 18 MB
Drug Development for Gene Therapy focuses on the translational and bioanalytical challenges and best practices for gene therapy modalities, presenting a significant body of data, including information related to safety and efficacy, necessary to advance through the development pipeline into clinical use. The text covers bioanalytical methods and platforms including patient screening assays, different PCR tests, enzyme activity assays, ELISpot, NGS, LC/MS, and immunoassays, with FDA and EMA guidelines on gene therapy safety and efficacy, along with companion diagnostics regulations from US and EU perspectives.