Development of methods for evaluating the impact of small design differences in the user interface of drug-device combination products on generic substitutability

The purpose of the research is to develop methods for evaluating the impact of small design differences in the user interface of generic drug-device combination products when compared to the user interface of the reference listed drug (RLD). The results obtained from this research will be used to gain a better understanding of the factors related to small design differences in the user interface that impact substitutability between generic and branded drug-device combination products in end-user groups.