Wednesday, 28.10.2020

Charles M. Beasley, Jr and Roy Tamura: What We Know and Do Not Know by Conventional Statistical Standards About Whether a Drug Does or Does Not Cause a Specific Side Effect (Adverse Drug Reaction )

 

Carlos Morra’s question to Charles Beasley

 

        Are there any infrequent-rare Adverse Drug Reactions, such as myocardial infarction aplastic anemia and Stevens-Johnson syndrome that you mentioned in your Commentary,  that can be effectively evaluated with intensive monitoring in Phase 1 studies, with or without the use of biomarkers?

 

October 3, 2019