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Nonclinical Evaluation Studies of Cellular and Gene Therapy Products
Strategies, Models, and Regulatory Frameworks
3 446 kr
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Beskrivning
- 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