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THE PHARMA REVIEW (MAY - JUNE 2011)

Biomarkers: Opportunities in Diagnostics and Therapeutics

Anantha Naik Nagappa And Vishnu Datta

Abstract: The Biomarkers have been making big news in diagnosis and therapeutics as they are revolutionizing the way the diseases are detected and treated. They are very important because they make the medicine from art to science, which is Evidence based Medicine form empirical treatments. Advances in biological sciences, analytical techniques, information technologies are conducive and converging into a cost effective diagnostics and therapies. There is no doubt that there will be paradigm changes in the way the diseases are diagnosed and treated due to biomarkers.
Introduction
A biomarker can be any of these such as a blood-based test, gene sequence or mutation, mRNA expression profile or tissue protein that can be used to provide Evidence of the state of an organism. It may be a traceable substance that is introduced into an organism as a means to examine organ function or other aspects of health. It can also be a substance whose detection indicates a particular disease state, for example, the presence of an antibody may indicate an infection. More specifically, a biomarker indicates a change in expression or state of a protein that correlates with the risk or progression of a disease, or with the susceptibility of the disease to a given treatment. Biomarkers are often used in the clinical trials as an indicator of normal biological processes, pathogenic
processes, or pharmacologic responses to a therapeutic intervention1.
The emerging field of biomarkers has applications in the diagnosis, staging, prognosis and monitoring of disease progression, as well as in the monitoring of clinical responses to a therapeutic intervention and the development and delivery of personalized treatments to reduce attrition in clinical trials. Moreover, biomarkers have a positive impact on health economics. The word ‘biomarker’ has been used extensively across therapeutic areas and many disciplines, and its nature takes into consideration clinical, physiological, biochemical, developmental, morphological and molecular measures. In drug trials, biomarkers have been proposed for use in efficacy determination and patient population stratification, in deducing pharmacokinetic–pharmacodynamics relationships and in safety monitoring. The interfacing and integration of different technologies for data collection and analysis are pivotal to biomarker identification, characterization, validation and application2.
The Biomarkers are extensively favoured in the clinical trials because it is an easy way to assess the functioning of vital organs in the body, the most of the biomarkers does not interfere with daily lifestyle. Hence the new era has started for the discovery of the biomarkers so for greater efficacy and accuracy getting and for a better patient compliance. Due to advent of Biomarkers, The fields of pathology and clinical pharmacology are in a phase of rapid evolution, reflecting continuous technological advancements in molecular diagnostics focused on improving drug efficacy and reducing toxicity. The discovery and refinement of the biomarkers are to be of greater prominence further understanding of research combined with emerging technologies such as functional imaging, biosensors, and sophisticated computational biology are having an unprecedented impact on the pharmaceutical industry3. Because of the diversity of the data types volumes and other characteristics there is no single process or solution that can address all data assimilation.

 

 

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