ABSTRACT
The sponsor’s interpretation of and contextualizing of the study results develop through the collaboration of clinicians, pharmacologists, and statisticians discussing the safety results and other important aspects in both the SCS and the review process. Worldwide regulators have emphasized safety monitoring as key to approving and maintaining a marketed drug. The sponsor’s interpretation of and contextualizing of the study results develop through the collaboration of clinicians, pharmacologists, and statisticians discussing the safety results and other important aspects in both the SCS and the review process. Mibefradil gained market approval in 1997 as a treatment for hypertension and angina. The initial product label listed three drug–drug interactions. The likelihood-based methods can apply to either experimental or observational data. Some methods, described later, such as the longitudinal LR test, have been applied to spontaneous report data as well as clinical trial data.
