Development: Preclinical Model Based Drug Development
Large scale in silico clinical development will only become a reality after some effort is exerted; some partial solutions (SB and BI tools mentioned in previous chapters) already exist and first attempts have been made. We acknowledge here that we are NOT in square zero and that in silico technologies have been, and are already being, used in clinical trial design and execution, used in simulation studies for adaptive trials, and used to identify patient subpopulations and markers for enrichment strategies. This goal will require a concentrated effort by all players, with considerable investment from the pharma industry and governments.
KeywordsClinical Trial Design Learning Cycle Process Analytical Technology Enrichment Strategy Adaptive Trial
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