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Browsing: gene therapy
Challenges and opportunities in bioanalytical support for gene therapy medicinal product development
This review article from Bioanalysis> summarizes recent practices and considerations in bioanalytical support of pharmacokinetics and pharmacodynamics evaluations in gene therapy development with insight into method design, development and validations.
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)
This part the 2018 White Paper published in Bioanalysis covers the recommendations for large molecule bioanalysis, biomarkers and immunogenicity using LBA and cell-based assays.