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- Inflammatory Bowel Disease (IBD)
- Inflammatory Myopathies
- Informed Consent
- Informed Consent Form
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC)
- Investigational New Drug Application
- Investigational New Drug Application (IND)
- IRT (Interactive Response technology)
- JAK inhibitor
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