- RANDOMIZED & BLIND TESTING - hundred to several thousand patients (1,000 to 3,000) and MORE DIVERSE (in age, sex, health etc) to confirm efficacy and safety. - provides the pharmaceutical company and the FDA with a MORE THOROUGH UNDERSTANDING OF THE EFFECTIVENESS of the drug or device - benefits and the range of possible ADR. - Complete>> a pharmaceutical company CAN REQUEST FDA APPROVAL for MARKETING THE DRUG. - In general, unless indicated by the Phase II studies, it is UNLIKELY THAT PATIENTS in Phase III studies will be UTILIZED FOR ROUTINE BIOPHARMACEUTIC, PHARMACOKINETIC EVALUATIONS - Phase III processes, PATIENTS WITH MORE THAN ONE DISEASE CONDITION WILL ENTER THE STUDY - The potential of other medications to effect or be affected by the test drug should then be examined carefully.