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Are In Vitro Drug Metabolism and Drug-Drug Interaction Studies Critical for an IND?

A Guide to What, Why & When to Conduct ADME Studies.

When drug developers are preparing their IND, drug metabolism and drug-drug interaction (DDI) studies often take a back seat to toxicity studies. However, benefits to drug development efficiency and expense, along with modern regulatory expectations, are causing many to look deeper earlier on in the development process.

We’re often asked, “When is it most beneficial to run these studies and which of these studies should be run?” To answer these questions, we compiled this article to outline:

  • Why run various ADME/DDI studies
  • When to conduct these studies
  • Proper study design and interpretation of the data

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