Scientifically Characterizing the Cellular Behavior in vivo to Promote High-Quality Development of Cell Therapy Medicinal Products
The rapid development of cell therapy technology has led to an important paradigm shift in the treatment of complex and refractory diseases,marking the arrival of a new therapeutic drug era represented by CAR-Ts approved in succession.Unlike that of new clinical technologies,necessary clinical pharmacology studies of cell therapy medicinal products should be carried out to make the cellular behavior in vivo clear and meet the regulatory requirements of new drug registration.The Center for Drug Evaluation of the National Medical Products Administration compiled"Technical Guidance for Clinical Pharmacology Research of Cell Therapy Medicinal Products",focusing on the characteristics of cellular behavior in patierts,elaborating on the relevant considerations of necessary studies on cellular kinetics and pharmacodynamics,exploring the key factors involving the safety and efficacy,in order to promote the high-quality development of cell therapy medicinal products in China.
cell therapy medicinal productschimeric antigen receptor-modified T cellstumor-infiltrating lymphocytesT cell receptor-engineered modified T cells
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维普
