Advanced applications, biomarker development

Advanced 2D-PAGE,2D-DIGE, and its Application for Biomarker Development... 

FIGURE 6.1 Conceptual diagram of fit for purpose biomarkers method validation. The method validation processes include four activity circles prevalidation (preanalytical consid eration and method development), exploratory method validation, in study method validation and advanced method validation. The processes are continuous and iterative, dictated by the purpose of the biomarker application. The solid arrows depict the normal flow of biomarker development (prevalidation), method validation (exploratory or advanced), and application (in study method validation). The process could include moving the chosen biomarkers from exploratory mechanistic pilot studies to advanced validation and confirmatory studies, or from exploratory validation to advanced validation after changes in critical business decision. The broken arrows represent scenarios where validation data do not satisfy study requirements, necessitating assay refinement or modification. 

Greater clarity on the most appropriate applications of pharmacogenetic and pharmacogenomic biomarkers in drug development is needed to advance the field. 

Recent advancements in genomics and proteomics have generated considerable interest in the discovery and validation of biomarkers in mechanism-based drug development [69-71], These advances have been welcomed to reduce the cost, increase success rates, and accelerate timelines in the drug discovery and development process. Herein, a brief overview of the application of biological markers in early discovery, development, toxicological assessments, and efficacy studies in humans is presented. 

Rapid determination of biomarkers of product origin and contamination has illustrated the capability of modem data analysis techniques in combination with advanced NMR systems. Characterisation of biological systems has also been performed in support of genetic improvement and for the detection and characterisation of the effects of genetic modification. These application-focussed studies have led to the development of the... 

Chapter 4 presents the recent advances in antibodies research and their applications for immunosensor development. Electrochemical immunosensors for metaUoproteins, nonmetaUoproteins, and cancer cells using their specific antibodies are emphasized. In Chapter 5, the essential components for the development ofbiosensors instrumentation are discussed. Virtual electrochemical instrumentation development using labVIEW is presented. Also, hand held microcontroUer-based electrochemical biosensors are assembled and applied for the measurement of various biomarkers including cytochrome c and nitric oxide metabohtes. These chapters provide the essential background knowledge and up-to-date advances in this field. The book should thus serve as an introductory text for those who intend to specialize in either the theoretical or practical apphcations. It is hoped that this textbook will be a fruitful launch pad for many careers in biosensors and bioelectronics. 

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