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The clinical research work of new drugs should be oriented from clinical value, and drug research and development should be carried out around the needs of patients
.
Problems that need to be solved in the development of new drugs should be found based on the needs of patients, and corresponding questions should be answered through clinical trials
.
The needs of patients, the problems that need to be solved in the development of new drugs, and the questions to be answered by clinical trials are all three in one, and none of them is indispensable (Figure 1)
.
.
Problems that need to be solved in the development of new drugs should be found based on the needs of patients, and corresponding questions should be answered through clinical trials
.
The needs of patients, the problems that need to be solved in the development of new drugs, and the questions to be answered by clinical trials are all three in one, and none of them is indispensable (Figure 1)
.
Figure 1 Clinical value-oriented new drug development based on patient needs
Figure 2 The research process of CAR-T cell therapy
Figure 3 Mechanism and advantages of CAR-T cell therapy
Figure 4 The market situation of CAR-T cell therapy
Figure 5 Overview of clinical trials of cell therapy
Figure 6 Target distribution of cell therapy
Figure 7 Bottleneck of CAR-T cell therapy for solid tumors
Figure 8 Research background of CLDN18.
2CAR-T cells
2CAR-T cells
Figure 9 Clinical study of CLDN18.
2 CAR-T cells
exist2 CAR-T cells
Figure 10 Summary of clinical studies of CLDN18.
2 CAR-T cells
2 CAR-T cells
Figure 11 Policy and regulatory history of immune cell therapy and related guidance documents
Figure 12 Whole-process supervision of cell and gene therapy
Figure 13 Considerations for clinical development of CAR-T cells and their special considerations as therapeutic products
Figure 14.
CAR-T cell clinical development guidelines issued by FDA
CAR-T cell clinical development guidelines issued by FDA
