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IND-Enabling Trial


What are IND-enabling trials? IND-enabling trials are primary exploratory studies that are conducted to evaluate the safety and efficacy of the drug.

These trials include non-clinical in-vitro and in-vivo studies to assess pharmacodynamics, pharmacokinetics, and toxicology of the drug. Examples of IND-enabling trials include:

  • Bridge assays
  • Immunogenicity testing
  • Monoclonal antibody development
  • Biomarker tissue analysis
  • Drug-drug interaction  sample analysis

Why are IND-enabling trials needed?

The data from the IND-enabling trials are used to prove safety of the efficacy and safety of an investigational drug to regulatory bodies for use in human clinical trials.

IND-enabling trials help:

  • Predict potential adverse effects
  • Allow estimation of starting doses.
  • Allow estimation of safe dosing ranges.

Source: FDA. (2021, February 24). Investigational New Drug (IND) Application. U.S. Food and Drug Administration. Retrieved July 1, 2022, from https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application