Non-clinical Pharmacokinetic Studies of Cell Therapy Products
As an emerging treatment,cell therapy shows great potential in a variety of diseases,especially refractory ones.Cell thera-py drugs include stem cells,immune cells and other terminally differentiated cells,which are reinfused into the body to achieve therapeu-tic effect after in vitro operation or genetic modification.However,given their unique biological characteristics,the pharmacokinetics(PK)study of cell therapy drugs presents many challenges.In this paper,we systematically review the PK characteristics of different kinds of cell therapy drugs,analyze the existing regulations and discuss the design of non-clinical PK studies and applicable bioanalytical methods of marketed drugs,to provide references for the development and evaluation of cell therapy drugs and promote the development and application in this field.
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