Best Practices for Development and Application of Disease Progression Models; Public Workshop
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Issuing agencies
Abstract
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research, are announcing a public workshop entitled "Best Practices for Development and Application of Disease Progression Models." The purpose of this public workshop is to discuss the best practices for developing disease progression models and their application to support drug development decisions, share experiences and case studies that highlight the opportunities and limitations in the development and application of disease progression models including models for natural history of disease and clinical trial simulations, and discuss the knowledge gaps and research needed to advance the development and use of disease progression models.
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