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Pharmacokinetic and bio-equivalency studies require very precise and accurate assay methods that are well-validated to quantify drugs in biological samples. The assay methods have to be sensitive enough to determine the biological sample concentration of the drug and/or its metabolite(s) for a period of about five elimination half-lives after the dosage of the drug. The assay methods also have to be very selective to ensure reliable data, free from the interference of endogenous98 compounds in the biological samples. In addition, methods have to be as robust and cost-effective as possible, making of particular importance to bioequivalent studies. Above all, the assay methods must be able to withstand the inspection of national drug registration authorities who judge them on the basis of criteria established by worldwide harmony.