Patient population phenotyping prior to clinical trials may improve drug development, CDER seminar told.
PATIENT POPULATION PHENOTYPING PRIOR TO CLINICAL TRIALS is one method for improving drug development, Robert Rubin, MD, Harvard/MIT Division of Health Sciences and Technology, told a Jan. 8 Center for Drug Evaluation & Research staff seminar. "The cornerstone of successful drug development is how well you characterize the patient prior to study entry and determine how well the patient fits carefully designed study entry criteria," he said.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth