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What is an Exploratory IND approach?

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Exploratory IND studies usually involve very limited human exposure and have no therapeutic or diagnostic intent, but such studies can serve a number of useful goals, such as:

  • Determining whether a mechanism of action defined in experimental systems can also be observed in humans (e.g. a binding property or inhibition of an enzyme)
  • Providing important information on pharmacokinetics (PK)
  • Selecting the most promising lead product from a group of candidates designed to interact with a particular therapeutic target in humans, based on PK or pharmacodynamic (PD) properties
  • Exploring a product’s biodistribution characteristics using various imaging technologies

Because exploratory IND studies present fewer potential risks than do traditional phase 1 studies that look for dose-limiting toxicities, such limited exploratory IND investigations in humans can be initiated with less, or different, preclinical support than is required for traditional IND studies.

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