Nonclinical Evaluation Studies of Cellular and Gene Therapy Products : Strategies, Models, and Regulatory Frameworks
Book Details
Format
Paperback / Softback
ISBN-10
0443486123
ISBN-13
9780443486128
Publisher
Elsevier - Health Sciences Division
Imprint
Elsevier - Health Sciences Division
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Oct 1st, 2026
Print length
1050 Pages
Weight
450 grams
Product Classification:
PharmacologyPharmacology
Ksh 47,900.00
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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.
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