Abstract
Abstract Analytical methods employed for the quantitative determination of drug substances and their metabolites in biological media play a significant role in the evaluation and interpretation of pharmacokinetic data. Small, “conventional” drug molecules are preferentially analyzed by chromatographic techniques and most emphasis has been on the validation of bioanalytical methods for such molecules. This article focuses on various validation issues associated with macromolecule bioanalysis and guidelines issued by regulatory authorities for bioanalytical method validation.
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