The IMP dossier (IMPD) gives information related to the quality of any IMP (i.e. including reference product and placebo), manufacture and control of the IMP, and data from non-clinical studies and from its clinical use. It is requred as part of a Clinical Trial Application in the EU for certain trials.
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Investigational Medicinal Product Dossier (IMPD)
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Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.
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The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.
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