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Drug development for gene therapy : translational biomarkers, bioanalysis, and companion diagnostics / edited by Yanmei Lu, Boris Gorovits.
- Format:
- Book
- Language:
- English
- Subjects (All):
- Gene therapy.
- Drugs--Design.
- Drugs.
- Genetic Therapy--methods.
- Biomarkers, Pharmacological--analysis.
- Drug Development--methods.
- Genetic Therapy.
- Drug Design.
- Medical Subjects:
- Genetic Therapy--methods.
- Biomarkers, Pharmacological--analysis.
- Drug Development--methods.
- Genetic Therapy.
- Drug Design.
- Physical Description:
- 1 online resource (xxiv, 465 pages) : illustrations (chiefly color)
- Place of Publication:
- Hoboken, New Jersey : John Wiley & Sons, Inc., [2024]
- Contents:
- Introduction to AAV-based in vivo gene therapy
- Recent development in in vivo clinical gene therapy platforms
- Overview of biomarkers for AAV gene therapy
- Nonclinical and Clinical Study Considerations for Biodistribution, Shedding and Pharmacokinetics / Pharmacodynamics
- Immunogenicity of gene therapy products
- Bioanalytical Methods To Detect Pre-existing and Post-administration Humoral Immune Responses Against AAV Capsid Proteins
- Bioanalytical methods to study biodistribution and shedding of AAV-based gene therapy vectors
- Transgene mRNA expression analysis
- Quantification of transgene protein expression and biochemical function
- Substrate and Distal Pharmacodynamic Biomarker Measurements for Gene Therapy
- Detection of cellular immunity to viral capsids and transgene proteins
- Detection of humoral response to viral capsids and transgene proteins
- rAAV integration : Detection and Risk Assessment
- Gene modification and integration for patient monitoring
- Introduction to companion diagnostics for gene therapy
- Validation for Gene Therapy Companion Diagnostics
- Regulatory considerations for gene therapy companion diagnostics
- Current regulatory landscape for gene therapy product development and the role of biomarkers.
- Notes:
- Includes bibliographical references and index.
- Electronic reproduction. Hoboken, N.J. Available via World Wide Web.
- Description based on online resource; title from digital title page (viewed on March 26, 2024).
- Other Format:
- Print version: Drug development for gene therapy
- ISBN:
- 9781119852810
- 1119852811
- 9781119852803
- 1119852803
- 9781119852797
- 111985279X
- Publisher Number:
- 90101015943
- Access Restriction:
- Restricted for use by site license.
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