ABSTRACT
This chapter focuses on plasma or serum, but the same discussion can be directed with appropriate modification to other biological matrices. For valid conclusions to be drawn from the results of bioequivalency testing, measured drug concentrations must be accurate, precise, and specific for the intact drug and bioactive metabolites. The chapter presents a brief overview of the analytical methods suitable for the assay of drugs and related compounds in biological matrices for bioequivalency studies. A presentation of the requirements of an assay for bioequivalency testing including the topics of sensitivity, accuracy, reproducibility, selectivity, and data reduction is given in this chapter. Interlaboratory correlation of a method is rarely needed in bioequivalency studies since each study is a discrete experiment in which the analysis is performed within a single laboratory. High-Performance Liquid Chromatography is the method of choice for analysis of drugs in biological fluids in bioequivalency studies.
