Read e-book online Biomarker Validation: Technological, Clinical and Commercial PDF

By Harald Seitz, Sarah Schumacher

ISBN-10: 3527337199

ISBN-13: 9783527337194

From the Contents:

• Biomarkers – previous and Future

• Quantitative Proteomics ideas in Biomarker Discovery

• Biomarker Qualification: a firm aspect of View

• Biomarker Discovery and scientific Diagnostic Imaging

• Breath: a frequently disregarded Medium in Biomarker Discovery

• HTA in custom-made medication Technologies

• Bone home improvement Biomarkers: New Actors at the outdated Cardiovascular Stage

• id and Validation of Breast melanoma Biomarkers

• evaluate of Proteomic information: From Profiling to community research when it comes to Biomarker Discovery

• Biomarkers: From Discovery to Commercialization

• scientific Validation

• Genomics and Proteomics for Biomarker Validation

For Biochemists, scientific Chemists, Oncologists, Laboratory Medics, and Analytical learn Institutes.

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Additional resources for Biomarker Validation: Technological, Clinical and Commercial Aspects

Example text

44. 45. problems in diagnostic accuracy studies: consequences and solutions. BMJ, 343, d4770. Global Harmonisation Task Force, Study Group 5 (2007) Clinical evaluation of biomarkers. org/dataoecd/45/58/41728174. pdf (accessed 07 November 2014). , and Huff, J. (2001) Clinical applications of pharmacogenetics. Trends Mol. , 7, 201–204. FDA Medical Devices In vitro Companion Diagnostic Devices. pdf/ (accessed 10 (2014) August. 2014). The Clinical Lung Cancer Genome Project (CLCGP) and Network Genomic Medicine (NGM) (2013) A genomicsbased classification of human lung tumors.

Pdf (accessed 07 November 2014). , and Mansfield, E. (2010) US FDA and 46. 47. 48. 49. 50. 51. 52. personalized medicine: in vitro diagnostic regulatory perspective. Pers. , 7, 517–530. Zhang, Z. (2012) An in vitro diagnostic multivariate index assay (IVDMIA) for ovarian cancer: harvesting the power of multiple biomarkers. Rev. Obstet. , 5, 35–41. S. html (accessed 13 November 2014). C. et al. (2013) Are companion diagnostics useful? Clin. , 59, 198–201. goo/downloads/Medical Devices/Device Regulations and Guidance/Guidance Documents (accessed 10 August.

Those accumulating novel data sets are highly complex and interrelated. Their interpretation 19 20 1 Biomarkers – Past and Future needs biomedical professionality and advanced analysis through the expertise of bioinformaticians [51]. Many exploratory biomarker data have still to reach a statistically validated significance. Moreover, novel candidate classes are worked on in clinical research, such as circulating DNA, various microRNAs, and circulating tumor cells. All of them will have to be submitted to a similar scrutiny for analytical and clinical validation.

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Biomarker Validation: Technological, Clinical and Commercial Aspects by Harald Seitz, Sarah Schumacher

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