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Reference ranges for screening preclinical drug safety data

¹R. W. Johnson Pharmaceutical Research Institute Rantan, New Jersey 08869-0602, USA.

Journal of Biopharmaceutical Statistics

|July 1, 1997

Summary

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Finite sample reference ranges improve preclinical drug safety screening by accurately identifying atypical values. A distribution-free method offers superior validity and efficiency over traditional large sample approaches.

Area of Science:

Pharmacology
Biostatistics
Toxicology

Background:

Reference ranges are crucial for identifying atypical data in preclinical drug safety studies.
Current methods, often based on large sample approximations, may inadequately detect unusual values.

Purpose of the Study:

To evaluate and improve methods for constructing finite sample reference ranges.
To enhance the accuracy of identifying atypical values in preclinical safety data.

Main Methods:

Modification of existing tolerance interval methods for reference range construction.
Definition and assessment of validity and efficiency criteria for reference ranges.
Comparison of finite sample methods against traditional large sample approaches.

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Main Results:

Traditional large sample methods may under-flag atypical values.
Modified tolerance interval methods provide more effective finite sample reference ranges.
A specific finite sample distribution-free method demonstrated superior performance.

Conclusions:

Finite sample reference ranges are more effective than large sample methods for preclinical drug safety.
The proposed finite sample distribution-free method is recommended for its validity and efficiency.