Reliable data obtained from selective, sensitive and reproducible analysis of a drug and its metabolites in biological samples is a fundamental and crucial part of every successful drug development program. Indeed, the same principles apply to many areas such as forensic science, toxicology and sports doping testing. The field of bioanalysis has matured significantly from early studies in drug metabolism using simple colorimetry. With the proliferation of sophisticated hyphenated techniques linking advanced separations with mass spectrometry and NMR as detection systems, automation and robotics, today's bioanalyst is well equipped to deal with the modern challenges of analyzing xenobiotics in biological matrices much faster and with a higher level of confidence. Furthermore, bioanalysts are now involved with the discovery, measurement and qualification of pharmacogenomic profiles and biomarkers and, subsequently, the development of diagnostic kits to individualize patient characterization and treatment. 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. Bioanalysis encourages the submission of any forward looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. In today’s highly competitive global drug development arena, it is more important than ever that the modern bioanalytical laboratory is optimized for speed and success.
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