In contrast to a traditional Investigational New Drug Application (IND), under which typically only one molecule can be investigated, an Exploratory IND provides a sponsor the opportunity to conduct early-stage clinical studies on a series of closely related molecules under the same IND. This provision, therefore, enables sponsors to select the most promising molecule, from a series of closely related molecules, for further development using human subjects. This article provides an overview of the advantages and limitations of this approach to drug development.
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21 CFR Part 312.23.
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Guidance for Industry, ICH S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals. Rockville, MD: Food and Drug Administration; July 1997.
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21 CFR Part 58.
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21 CFR part 210 and 211.
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Guidance for Industry: INDs—Approaches to Complying With cGMP During Phase 1. Draft Guidance. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center of Biologics Evaluation and Research, cGMP; January 2006.
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Position Paper on Non-clinical Safety Studies to Support Clinical Trials With a Single Microdose. London: European Medicines Agency, Committee for Medicinal Products for Human Use; June 2004. CPMP/SWP/2599/02/Rev 1.
