An Application of a Statistical Approach to the Calibration and Validation of Analytical Assays for Investigations Drugs: Quantitation of CGP19984D, A Thiazolidinedione Derivative with Antitumor Activity, and its Two Diastereomers in Biological Fluids by High Performance Liquid Chromatography

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Abstract
A set of statistical procedures has been developed for: 1) the construction of linear standard curves for cases in which the sensitivity of the assay spans a 1000-fold range; 2) the estimation of unknown compound concentrations with associated fiducial limits; 3) the validation of the assay; and 4) the generation of appropriate quality control charts. This statistical methodology was applied to a new investigational drug, CGP19984D. CGP19984D is a thiazolidinedione derivative that suppresses gonadal function and inhibits tumor growth in both hormone-dependent and hormone-independent mammary and prostatic adenocarcinoma in the rat. This compound has undergone extensive pharmacologic and toxicologic evaluation in preparation for Initial clinical trial in man. This paper describes the an alytical procedure that has been developed to quantitate the two diastereomers of CGP19984D in plasma and urine and the statistical evaluation of this procedure.

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