TITRATED EARLY-STAGE CLINICAL STUDIES COULD "BE CONSIDERED"

Executive Summary

TITRATED EARLY-STAGE CLINICAL STUDIES COULD "BE CONSIDERED" as the type of study "to guide the rest of development, to convince yourself you have a drug," Office of Drug Evaluation I Director Robert Temple, MD, suggested on June 8 at the Drug Information Association annual meeting in Washington, D.C. A titration design could save time in the full clinicals in the development of drugs for "hypertension, angina, maybe heart failure, probably chronic pulmonary diseases, certainly chronic pain, cholesterol [and] blood sugar," Temple maintained.