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Editorial
. 2023 Feb;43(2):171-176.
doi: 10.1002/cac2.12400. Epub 2023 Jan 22.

Criteria and regulatory considerations for the conditional approval of innovative antitumor drugs in China: from the perspective of clinical reviewers

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Editorial

Criteria and regulatory considerations for the conditional approval of innovative antitumor drugs in China: from the perspective of clinical reviewers

Limin Zou et al. Cancer Commun (Lond). 2023 Feb.
No abstract available

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Figures

FIGURE 1
FIGURE 1
Applicability decision tree of the working procedures for conditional approval of innovative antitumor drugs. Abbreviations: RCT, randomized controlled trial; ORR, objective remission rate; CRR, complete remission rate; DOR, duration of remission; PFS, progression‐free survival; DFS, disease‐free survival; EFS, event‐free survival; OS, overall survival.

References

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    1. NMPA . Measures for the Administration of Drug Registration. Beijing. 2020.
    1. NMPA . Review Procedures for Breakthrough Therapy Drugs (Trial). Beijing. 2020.
    1. Zou LM, Du Y, Qi YL, Tang L, Yang ZM. Considerations on granting breakthrough therapy designation in oncology. Chin J Clin Pharmacol. 2021;37(11):1471‐1475.
    1. NMPA . Review and Approval Procedures for Conditional Approval of Drugs (Trial). Beijing. 2020.

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