Sage Journals: Discover world-class research

Abstract

Ortho Pharmaceutical Corporation's automation of the Drug Safety Evaluation area involves a distributed computer system. 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. Data can be transferred from the minicomputer to a mainframe computer for statistical analyses. The following major system components were developed internally by Ortho: a Protocol System, a Clinical Pathology System, an In-Life General Toxicology System, and the communications software. Those facets acquired from vendors include a Necropsy/Pathology System (Beckman TOXSYS) and a Reproductive Toxicology/Teratology System (SAIC TEROS). All internal systems development made use of structured analysis, design, programming, and testing techniques. Those systems acquired externally were subjected to rigorous testing and validation prior to acceptance. The Ortho Drug Safety Evaluation automated system is now operational and is running in production mode in the Preclinical Research and Development division.

Keywords

Drug safety evaluation Toxicology Computerization Distributed system Database

Get full access to this article

View all access options for this article.

References

Frith

: Automated and computer-assisted pathology support for a large chronic study. J Environ Pathol Toxicol 1979; 3:231–246.

Herrick

Green

Ezell

: NCTR computer systems designed for toxicologic experimentation. V: Post-experiment information system. J Environ Pathol Toxicol 1979; 3:315–327.

Herrick

Davis

Donnelly

: Histopathology automated system. Drug Inf J 1983; 17: 287–295.

Jogwick

Drew

Greenberg

: Merck preclinical system development in a GLP environment. Drug Inf J 1978; 12:230–233.

Kellenbenz

Mosher

Teal

: Interactive pathology/toxicity computer system. Drug Inf J 1978; 12:174–180.

McGuire

Shih

DiFonzo

: Toxicology laboratory interactive computer-based data acquisition and information systems. Drug Inf J 1981; 15:181–188.

Nadasky

Mellos

Senkbeil

: Data collection, analysis and reporting of a reproductive drug safety study in rats and mice: a computer based system. Drug Inf J 1973; 7:13–23.

Pronchik

: Computerized reproductive toxicology system using System 1022. Drug Inf J 1983; 17:77–87.

Robertson

: Drug safety-evaluation using computerized data processing. Pharm Tech 1982; 2: 50–54, 68.

10.

Small

Hatfield

SmitRoeters

: Recording and retrieval of chronic animal toxicology data. Drug Inf J 1973; 7:26–36.

11.

Small

Young

Shoaff

: Collection, storage, retrieval, and analysis of toxicological data using automated equipment and packaged software. Drug Inf J 1976; 10:7–12.

12.

Taylor

Johnson

: Data systems support for a large, long-term carcinogenic (ED01) study. J Environ Pathol Toxicol 1980; 3:221–230.

13.

Ray

, (ed): SAS User's Guide: Basics, 1982 Edition. Cary, NC, SAS Institute, 1982.

Drug Safety Evaluation Automation: A Distributed System Approach

Abstract

Keywords

Get full access to this article

References