The role of data organization in the evaluation of toxicology studies in drug application.

Abstract

One goal of the FDA's ongoing New Drug Regulations rewrite project is to facilitate and expedite drug application review. We believe that this can be aided by improved and consistent organization of the submissions. Therefore, guidelines are being developed to assist applicants in preparing well-structured summaries and full report sections. The proposed format guideline for toxicology and related studies is not intended to increase the amount of documentation beyond what is already required by the GLP regulations, but rather to provide some principles for orderly and coherent submission to aid comparative review of various types of data within and between studies. Certain of these principles may also be applicable to submission of data during the IND. The computer's role as an important, even essential, adjunct to this process is clearly evident. However, it is particular important that data automation be flexible enough to recognize and reconcile the differing perspectives of data collection and storage, and data retrieval and organization to benefit scientific evaluation of a drug application. Examples of recurring problems in the submission of computerized toxicology data are presented to illustrate their frustrating or confounding effect on the scientific evaluation of drug applications.