Abstract
Biomarkers are any measurable and quantifiable biological parameters which serve as indices for health- or disease-related processes. The idea of identifying biological markers as indicators for an underlying disease is an elementary concept in medicine. Since the beginning of the medical skill of healing, signs and symptoms have been interpreted by medical doctors and guided diagnosis and treatment of their patients. With the emergence of the bioanalytical laboratory methods in the 50s of the last century a number of novel serum and urine markers became available. These objectively measurable serum markers were initially intended for studying physiological processes in biology. Over time, the value of such serum based biological markers for clinical decision making emerged as they were correlated with the pathology and the clinical course of disease states. This “traditional identification” of biomarkers as an observational site product of clinical practice led to the identification of the majority of clinical biomarkers employed in clinical practice today.
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References
Biomarkers Definitions Working Group (2001) Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 69(3): 89–95
Oldenhuis CN, Oosting SF, Gietema JA, de Vries EG (2008) Prognostic versus predictive value of biomarkers in oncology. Eur J Cancer 44(7): 946–953
Gobburu JV, Marroum PJ (2001) Utilisation of pharmacokinetic-pharmacodynamic modelling and simulation in regulatory decision-making. Clin Pharmacokinet 40(12): 883–892
Wacheck V (2004) Strategies for designing clinical trials for oligonucleotide therapeutics. Drug Discov Today 9(21): 918–923
Vasan RS (2006) Biomarkers of cardiovascular disease: molecular basis and practical considerations. Circulation 113(19): 2335–2362
Lee JW, Hulse JD, Colburn WA (1995) Surrogate biochemical markers: precise measurement for strategic drug and biologics development. J Clin Pharmacol 35(5): 464–470
Hargreaves R (2002) Imaging substance P receptors (NK1) in the living human brain using positron emission tomography. J Clin Psychiatry 63(Suppl 11): 18–24
Parulekar WR, Eisenhauer EA (2004) Phase I trial design for solid tumor studies of targeted, non-cytotoxic agents: theory and practice. J Natl Cancer Inst 96(13): 990–997
Spear BB, Heath-Chiozzi M, Huff J (2001) Clinical application of pharmacogenetics. Trends Mol Med 7(5): 201–204
Mok TS, Wu YL, Thongprasert S, et al. (2009) Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361(10): 947–957
Boissel JP, Collet JP, Moleur P, Haugh M (1992) Surrogate endpoints: a basis for a rational approach. Eur J Clin Pharmacol 43(3): 235–244
Espeland MA, O’leary DH, Terry JG, Morgan T, Evans G, Mudra H (2005) Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors. Curr Control Trials Cardiovasc Med 6(1): 3
Prentice RL (1989) Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 8(4): 431–440
Arber N, Levin B (2008) Chemoprevention of colorectal neoplasia: the potential for personalized medicine. Gastroenterology 134(4): 1224–1237
Law MR, Wald NJ, Rudnicka AR (2003) Quantifying effect of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ 326(7404): 1423
Ridker PM, Danielson E, Fonseca FA, et al. (2008) Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 359(21): 2195–2207
Kastelein JJ, Akdim F, Stroes ES, et al. (2008) Simvastatin with or without ezetimibe in familial hypercholesterolemia. N Engl J Med 358(14): 1431–1443
Duivenvoorden R, de GE, Stroes ES, Kastelein JJ (2009) Surrogate markers in clinical trials — challenges and opportunities. Atherosclerosis 206(1): 8–16
Rossebo AB, Pedersen TR, Boman K, et al. (2008) Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis. N Engl J Med 359(13): 1343–1356
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Wacheck, V. (2010). Biomarkers. In: Müller, M. (eds) Clinical Pharmacology: Current Topics and Case Studies. Springer, Vienna. https://doi.org/10.1007/978-3-7091-0144-5_16
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DOI: https://doi.org/10.1007/978-3-7091-0144-5_16
Publisher Name: Springer, Vienna
Print ISBN: 978-3-7091-0143-8
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