Industry Perspective on Computer Assisted Toxicology/Pharmacology Review

Experience with Computer-Assisted New Drug Application (NDA) Review (CAN-DAR) techniques, particularly in the clinical section, has demonstrated benefits to the Food and Drug Administration (FDA) and sponsoring drug companies. Both Pharmaceutical Manufacturers Association (PMA) and FDA are interested in developing the capability of CANDAR for toxicology/pharmacology data. The goals are to 1. decrease time from original NDA submission to approval; 2. facilitate rapid assimilation of a large amount of drug safety data; 3. provide easy access to drug safety data to minimize unproductive search time; and 4. provide enhanced capability to scientifically analyze and evaluate data. For optimal development of a CANDAR system, the current review process should be thoroughly understood, complex time-consuming tasks should be identified, and major problems should be analyzed. Systems design and analysis techniques are useful to define requirements for a CANDAR system that meets the needs of the FDA and drug companies. A committee composed of PMA and the FDA members has been formed to work on development of a CANDAR system. The joint committee is currently in the very early stages of identifying needs and defining functional requirements