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A Regulatory Landscape Shift for In Silico Clinical Trials
Published on: Jan 24, 2020
Modelling and simulation (M&S) has grown to become a reliable approach to better understand and optimize key decisions related to safety, efficacy, dosing, and special target populations. As both computing power and our understanding of human systems biology improve, the increased use of M&S motivates regulators to consider this new type of digital evidence to support medical device and medicinal drug product development and allow new approaches in clinical trials, in view of increasing the probability of success, reduce costs and accelerate time to patients.
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