Abstract

Srijita Dutta*

ABSTRACT

Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing, analysis cost and environmental impact. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. With this emphasis in the use of PK/toxicokinetics and the greater potencies of newer drugs, a sensitive and specific bioanalytical technique is essential. Many scientific endeavors are dependent upon accurate quantification of drugs and endogenous substances in biological samples; the focus of bioanalysis in the pharmaceutical industry is to provide a quantitative measure of the active drug and/or its metabolite(s) for the purpose of pharmacokinetics, toxicokinetics, bioequivalence and exposureresponse (pharmacokinetics/pharmacodynamics studies). Bioanalysis also applies to drugs used for illicit purposes, forensic investigations and environmental concerns. The need for sound bioanalytical methods is well understood and appreciated in the discovery phase and during the preclinical and clinical stages of drug development. Therefore, it is generally accepted that sample preparation and method validation are required to demonstrate the performance of the method and the reliability of the analytical results. Now it is widely accepted that bioanalysis is an integral part of the pharmacokinetic/pharmacodynamic characterization of a novel chemical entity from the time of its discovery and during various stages of drug development, leading to its market authorization.