IND-Enabling Studies
The specific set of preclinical studies required by regulatory agencies to support an Investigational New Drug application and initiate first-in-human clinical trials. Includes GLP toxicology (acute and repeat-dose), genotoxicity, safety pharmacology (cardiovascular, respiratory, CNS), PK/ADME characterization, and chemistry/manufacturing/controls (CMC) documentation. Typically takes 12-18 months and costs $2-5 million.
例
- 14-day GLP toxicology study in two species
- hERG channel assay for QT prolongation risk
- Ames test and in vivo micronucleus for genotoxicity
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The specific set of preclinical studies required by regulatory agencies to support an Investigational New Drug application and initiate first-in-human clinical trials. Includes GLP toxicology (acute and repeat-dose), genotoxicity, safety …