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What is an Exploratory IND approach?

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Proxima CRO Team
Alisa Hamilton
Mgr. of Ops, Marketing & Comms.
Alisa graduated from Stephen F. Austin State University with a B.B.A in May of 2016, where she was a 4-year letterman scholarship-athlete. She has over eight years of business management experience in healthcare.

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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