The Validation of Analytical Assays for Biopharmaceutical Studies

GERALD K. SHIU

Biopharmaceutics Research Laboratories HFD-424, Food and Drug Administration 200 C Street, S. W. Washington, D. C.20204

ABSTRACT

   The information required for an adequate analytical method validation for either in vitro or in vivo biopharmaceutical studies is discussed in this article. The most commonly applied assay parameters: accuracy, precision, detection limit, specificity, selectivity, calibration linearity or nonlinearity, stability, recovery, reproducibility and repeatability are carefully defined along with some recommendations required for assessing data acceptability arrived at the conference on Analytical Methods Validation. Though more specific analytical issues concerning microbiological assay radioimmunoassay and stereoisomer assay were not examined, this article should provide good guidance to pharmaceutical chemists to properly perform analytical method validation and carry out routine analysis.

Key words:analytical method,validation, quality control, calibration