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Abstract

The Ortho Pharmaceutical Corporation automated system for Drug Safety Evaluation consists of the following components: a Protocol System, a Clinical Pathology System, an In-Life General Toxicology System, a Necropsy/Pathology System (Beckman TOXSYS), a Reproductive Toxicology/Teratology System (SAIC TEROS), and communications software. The system is based on a distributed computing scheme in which microcomputers are used for data collection and local report generation. A minicomputer serves as the host machine for scheduling and monitoring data collection activities, and houses the centralized study databases. The addition of an On-Line Study Log is a major step toward our goal of the “paperless laboratory.” The On-Line Study Log is an operational component of the Ortho Drug Safety Evaluation automated system in the Preclinical R&D division.

Keywords

Drug safety evaluation Toxicology Computerization Study log Database

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A Drug Safety Evaluation On-Line Study Log

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