Evaluations of the toxic potential of drugs and chemicals often involve statistical comparisons of effects between treatment groups. Such comparisons are valid and permit elucidation of spontaneous versus treatment effects only if the sampling population is obtained without selection bias. Selection bias is routinely minimized or controlled by random sampling or unbiased allocation of animals to treatment groups. A systematic approach using a computerized procedure is described that fulfills these requirements in a simple and efficient fashion.

No abstract

A microcomputer-based system has been developed for the acquisition, reporting, and evaluation of clinical biochemistry and hematologic data. The system consists of an IBM microcomputer interfaced with several peripheral devices. Associated com puter programs were developed inhouse and customized for use in animal drug toxicity studies. The system has the following advantages: (1) Data are directly transmitted to the microcomputer via interface devices, thereby minimizing the pos sibility of data entry errors and eliminating the need for handwritten records; (2) individual animal reports and group summary reports are readily generated; (3) individual animal data and group summary values are routinely compared during the data collection phase against a historical reference range database, and "outliers" are flagged, allowing quick identification of aberrant values or parameters that may have been affected by experimental treatments; and (4) treatment groups are tested in the data evaluation phase against control groups for statistically significant differ ences, which are automatically flagged in the summary tables. This microcomputer system has also assisted in Good Laboratory Practice audits and quality control monitoring.ALTHOUGH computer systems for han dling clinical pathology data from pa tients in a hospital setting have been exten sively developed, computer systems to meet the unique requirements of clinical

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