All Times EDT
Keywords: Study designs for demonstrating contribution of component; drug combination regimen;
Adequate and well-controlled clinical studies are required for applications to market a new drug or biologic. The design of the pivotal clinical studies may vary substantially depending on the investigational drug product, the specific indication for labeling claim, and available resources and existing study results. For combination regimens, the drug development strategy should also be able to demonstrate the individual contributions of each component, which will be especially difficult for novel drug combinations. This presentation will discuss the potential study designs for combination regimen and will also discuss an example of novel drug combinations.