Model-based clinical drug development in the past, present and future: a commentary
作者： Holly Kimko , José Pinheiro
DOI: 10.1111/BCP.12341
关键词:
摘要: Clinical drug development remains a mostly empirical, costly enterprise, in which decision-making is often based on qualitative assessment of risk, without properly leveraging all the relevant data collected throughout programme. Model-based (MBDD) has been proposed by regulatory agencies, academia and pharmaceutical companies as paradigm to modernize research through quantification risk combination information from different sources across time. We present here historical account use MBDD clinical development, current challenges further opportunities for its application industry.
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