FDA Review of IND 1. Reasons for clinical hold Human subjects would be exponsed to significant risk Clinical investigators are unqualified Investigators brochure is inadequate Other information is missing or inadquate in the IND 6. A.K.A. Clinical Pharmacology Studies Goals Primary Goal is to determine safety of drug 1. Tolerance of drug. Presence of AEs as dose is increased.
Major use is to select starting dose for effectiveness studies.
Secondary goals are to obtain metabolism, disposition and excretion data. Phase I can refer to both a Time of study, and a Type of study. Often drug is given to one group and a placebo given to another group Randomized and blind to patients and physicians 4. Take blood, etc. for subsequent analysis 5. Often monitor over successive days or weeks with lab test, blood sampling, etc.