Enhancing NDA'S with Graphics: An Integrated System for Production and Presentation Graphics

The use of color graphs can enhance New Drug Applications in two distinct ways: (1) by summarizing overall study results in a clear, forceful, and aesthetically pleasing way, and (2) by presenting a large amount of data concisely in an understandable format. A parallel distinction is drawn between “presentation” and “production” modes of generating graphs, each with its own input and output requirements, time constraints, degree of standardization, hardware, and software. Hoechst-Roussel Pharmaceuticals Inc (HRPI) employs a network of computers, graphics devices, and software packages to handle the diverse needs of both types of graph. This complex system is simplified by a system of user and requestor support that includes a dictionary of prototypes and a user friendly interactive front end. Currently, near presentation-quality graphs are generated at close to production speeds with the aid of program-generating programs. Upgrades in hardware will narrow the gap, resulting in production-volume output that approaches presentation-quality appearance.