Nonclinical Evaluation Studies of Cellular and Gene Therapy Products

Strategies, Models, and Regulatory Frameworks

1050 Seiten, Taschenbuch

Kurzbeschreibung des Verlags

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.

• Themen: Medizin Medizinische Spezialgebiete Pharmakologie
• ISBN: 9780443486128
• Sprache: Englisch
• Erscheinungsdatum: 26.06.2026
• Verlag: Elsevier Science
• Herausgegeben von: Xingchao Geng, Qingli Wang, Quanjun Wang