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”
THE UNIVERSITYOF NEW MEXICO▪ HEALTH SCIENCES CENTER
Exploratory IND Studies
Michael Briggs, Operations Director
Human Research Protections
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.