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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.

I

Investigational New Drug (IND)

The Investigational New Drug (IND) is a regulatory filing submitted to the FDA (Food and Drug Administration) in the United States prior to conducting clinical trials of a new drug in humans.The IND application contains information on the drug substance, including its composition, manufacturing process, and quality control testing results. It also includes data from non-clinical studies, such as animal toxicology and pharmacology data, as well as a plan for clinical trials in humans.The purpose of the IND application is to provide the FDA with sufficient information to determine whether the proposed clinical trials of the new drug are safe and scientifically sound, and whether the potential benefits of the drug outweigh the potential risks.The IND application is typically filed by the sponsor or developer of the new drug, and must be reviewed and approved by the FDA before the clinical trials can proceed. The FDA may require additional information or changes to the clinical trial plan before granting approval of the IND application.