A modelling framework for improved design and decision-making in drug development.

ABSTRACT: The development of a new drug is an extremely high-risk enterprise. The attrition rates of development projects and the average costs for each launched product are daunting, and the completion of a development program requires a very long time horizon. These facts imply that there are huge potential gains, should one be able to improve efficiency and enhance decision-making capabilities. In this paper, we argue that substantial gains can be achieved by adapting a holistic view of drug development. Historically, too much planning, design and decision-making in the pharmaceutical development has been based on locally optimising separate parts of the development program, and too often important sources of uncertainty are ignored. We propose instead a model-based approach built on two essentia

SUBMITTER: Wiklund SJ 

PROVIDER: S-EPMC6713335 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature