Industry Perspective on Computer Assisted Toxicology/Pharmacology Review

Abstract

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 devel­ oping 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 capabili­ ty to scientifically analyze and evaluate data. For optimal development of a CAN­ DAR 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 CAN­ DAR 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.