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Term of the Day

Natural History Study

A natural history study is a preplanned intended to track the course of the disease. Its purpose is to identify demographic, genetic, environmental, and other variables (e.g., treatment modalities, concomitant medications) that correlate with the disease’s development and outcomes. Natural history studies are likely to include patients receiving the current standard of care and/or emergent care, which may alter some manifestations of the disease.

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Investigational Medicinal Product Dossier (IMPD)

An Investigational Medicinal Product Dossier (IMPD) is a regulatory document that provides a comprehensive overview of an investigational product being tested in a clinical trial. The IMPD is submitted to regulatory agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) as part of the drug development process.The IMPD contains detailed information on the investigational product, including its manufacturing process, composition, stability, and quality control testing results. It also includes data on non-clinical studies, such as animal toxicology and pharmacology data, as well as clinical trial data from previous trials.

The IMPD is used by regulatory agencies to evaluate the safety, quality, and efficacy of the investigational product. It provides a detailed description of the product and its development history, and serves as a reference for regulators in their evaluation of the product.