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Term of the Day
Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.
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.