Nonclinical Evaluation Studies of Cellular and Gene Therapy Products: Strategies, Models, and Regulatory Frameworks - Image 1

£224.57

Elsevier Nonclinical Evaluation Studies of Cellular and Gene Therapy Products: Strategies, Models, and Regulatory Frameworks

Name: Nonclinical Evaluation Studies of Cellular and Gene Therapy Products: Strategies, Models, and Regulatory Frameworks
Brand: Elsevier
Price: 224.57 GBP
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Description

Nonclinical Evaluation Studies of Cellular and Gene Therapy Products: Strategies, Models, and Regulatory Frameworks systematically explores the nonclinical evaluation of Cell and Gene Therapies (CGT) products, emphasizing risk mitigation and innovation. The book provides comprehensive coverage, including 20+ chapters spanning preclinical toxicology, pharmacokinetics, and novel evaluation models. It is the first book to integrate organ-on-chip models into CGT evaluation, reflecting FDA/NMPA modernization initiatives. It includes practical guidance on addressing CRISPR off-target effects, immunogenicity, and long-term carcinogenicity risks. Includes definitions, regulatory policies (US, EU, China), and quality control requirements Provides in-depth coverage of humanized animal models, organ-on-chip systems, and 3D bioprinted tissues for toxicity screening Covers evaluation strategies for mRNA drugs, exosome-based therapies, and red blood cell-mediated drug delivery Includes case studies: FDA-approved CRISPR therapies, CAR-T safety assessments, and lessons from failed trials

Product Specifications

Brand: Elsevier
Format: paperback
ASIN: 0443486123
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Other Branches of Medicine
Domain: Amazon UK
Release Date: 05 October 2026
Listed Since: 26 February 2026

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Elsevier Nonclinical Evaluation Studies of Cellular and Gene Therapy Products: Strategies, Models, and Regulatory Frameworks

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