Preclinical safety testing for cell-based products using animals
Author:
Publisher
Elsevier BV
Subject
Pharmacology,General Immunology and Microbiology,Applied Microbiology and Biotechnology,General Medicine,Bioengineering,Biotechnology
Reference8 articles.
1. In question: the scientific value of preclinical safety pharmacology and toxicology studies with cell-based therapies;Broichhausen;Mol Ther — Meth Clin Dev,2014
2. ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
3. ICH S7A note for guidance on safety pharmacology studies for human pharmaceuticals CHMP/ICH/539/00.
4. Case report of a serious adverse event following the administration of T cells transduced with a chimeric antigen receptor recognizing ERBB2;Morgan;Mol Ther,2010
5. Cardiovascular toxicity and titin cross-reactivity of affinity-enhanced T cells in myeloma and melanoma;Linette;Blood,2013
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2. Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective;Pharmaceutical Research;2018-08
3. Scientific considerations for the regulatory evaluation of cell therapy products;Biologicals;2017-11
4. Comprehensive toxicity and immunogenicity studies reveal minimal effects in mice following sustained dosing of extracellular vesicles derived from HEK293T cells;Journal of Extracellular Vesicles;2017-06-06
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