Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China

Wang, J; Wang, G; Li, M; Han, JJ; Zeng, X; Pan, JH; Yang, JB

Yang, JB (reprint author), CFDA, CDE, Off Biostat & Clin Pharmacol, A-1 Fuxing Rd, Beijing 100022, Peoples R China.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2019; 53 (2): 227

Abstract

Data quality is critical for clinical trials to obtain robust conclusions about drug safety and efficacy evaluation. Effective data quality evaluation......

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