T HE U NIVERSITY OF N EW M EXICO ▪ H EALTH S CIENCES C ENTER. Exploratory IND Studies. Michael Briggs, Operations Director Human Research Protections [email protected] 272-1147. August 2006. Topics. General Overview of IND Types & Components Focus on “ Exploratory IND”
Clinical exploratory approach to enable sponsors to more efficiently identify and develop promising compounds under an IND, based on a more limited preclinical data set than that required for a traditional Phase 1 study.
Depending on type of study (3 examples)
Repeat Dose Toxicity (repeat dosing “ok” if separated by 1 week)
Not required for ExpIND
Note: Seek guidance from M.Briggs relating to GMP/GLP issues when planning IND study.