Model-based clinical drug development in the past, present and future: a commentary

被引：44

作者：

Kimko, Holly ^{[1
]}

Pinheiro, Jose ^{[1
]}

机构：

[1] Johnson & Johnson, Janssen Res & Dev LLC, Model Based Drug Dev, Raritan, NJ 08869 USA

来源：

BRITISH JOURNAL OF CLINICAL PHARMACOLOGY | 2015年 / 79卷 / 01期

关键词：

clinical trial simulation; model-based drug development; modelling; PK; PD; simulation; CELL LUNG-CANCER; DECISION-MAKING; SENSITIVITY-ANALYSIS; LABELING DECISIONS; SIMULATION; PHARMACOKINETICS; PHARMACOMETRICS; PHARMACOLOGY; TRIALS; PHARMACODYNAMICS;

D O I：

10.1111/bcp.12341

中图分类号：

R9 [药学];

学科分类号：

1007 ;

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 the development programme. Model-based drug development (MBDD) has been proposed by regulatory agencies, academia and pharmaceutical companies as a paradigm to modernize drug research through the quantification of risk and combination of information from different sources across time. We present here a historical account of the use of MBDD in clinical drug development, the current challenges and further opportunities for its application in the pharmaceutical industry.

引用

页码：108 / 116

页数：9

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