Get 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 strategies in Biomarker Discovery

• Biomarker Qualification: an organization element 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 previous Cardiovascular Stage

• identity and Validation of Breast melanoma Biomarkers

• evaluate of Proteomic info: From Profiling to community research in terms of Biomarker Discovery

• Biomarkers: From Discovery to Commercialization

• scientific Validation

• Genomics and Proteomics for Biomarker Validation

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

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

Example text

Clinical utility has to be proved to reach acceptance by the medical community, regulatory authorities, and willingness of healthcare payers for reimbursement. This is written even though by common sense the benefits of biomarker testing for patients and physician may be obvious to the developers. When industrial providers are going to introduce a biomarker product to the market a variety of information will be needed in order to verify the clinical relevance of testing and to provide its evidence in order to reach a broad clinical exploitation [36, 39].

The accuracy of a biomarker assay or a combination of biomarkers in a diagnostic model is proved by their ability to • identify a target disease in a patient, • differentiate between diseases with similar clinical symptoms, or • predict a patient’s response to treatment or monitor effects of therapy on the patient’s disease burden. For validation of a pattern recognition model in discovery-based research the biostatistics of overfitting can become a problem [35]. It can be reduced by splitting the tested population into two groups, that is, a training set and an independent validation set, both endowed with biostatistically sufficient group sizes.

In MALDI MSI experiments there is always a compromise between spatial resolution and analyte extraction efficiency. The better the quality of the matrix the better the analyte extraction efficiency, but the spatial resolution decreases due to bigger droplets on the tissue. The best spatial resolution can be achieved by sublimation of the matrix. Therefore the matrix is directly transferred from the solid phase into the gas phase and used for solvent-free coating of the samples. This procedure prevents spreading of analytes in the deposited matrix droplets.

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

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