Abstract
Clinical drug development can be viewed as a sequence of steps starting when a drug candidate is first used in man and ending when the accumulated information is presented to the regulatory authority to obtain market approval. At each step the available information is analysed and a decision is made to continue to the next step. Over the last decade there has been an increasing interest in the use of modelling to increase the speed and success of drug development. It has been recognized that modelling and simulation may help in (1) extracting information from data and integrating information from different sources; (2) better understanding what happens with a drug in new conditions, such as another patient group or a different dosing regimen and (3) optimizing the design of clinical trials. In this paper, a general framework of clinical drug development is described, focussing on the features that make the application of modelling and simulation worthwhile. A brief overview of the kind of models that are used is given. Two published examples of how modelling and simulation contributed to decision making in clinical drug development are discussed.
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