Correlates of time to approval and other clinical development periods.
作者： Christopher D. Breder , Margaret VanHeusen , Lin-Chau Chang
DOI: 10.1016/J.DRUDIS.2019.05.027
关键词: Large population 、 Medicine 、 Drug 、 Drug development 、 Duration (project management) 、 Phase (combat) 、 MEDLINE 、 Intensive care medicine
摘要: The drug development cycle is classically divided into a clinical phase and review phase, with the typically being further partitioned based on planning conduct of adequate well controlled trials. Factors affecting duration intervals have not previously been systematically investigated. Here, we analyze large population (N=825) New Drug Applications (NDAs) approved between 2008 2017 to characterize typical these factors associated their duration. These data analyses will help those involved in pharmaceutical by enabling data-driven providing insight effect certain programs.
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