Biomarkers in Clinical Drug Development (Drugs and the by John Bloom, Richard A. Dean

By John Bloom, Richard A. Dean

Featuring functions in scientific improvement, pharmacokinetic/ pharmacodynamic modelling and scientific trial simulation, this reference experiences the position of biomarkers in profitable drug formula and improvement.

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6 a Methods 1– 11 are NGSP certified. Assigned as the mean value of six replicate analyses over 2 days using four NGSP-certified secondary reference methods. c Single manufacturer. Source: Data obtained from NGSP website and used with the permission of the National Glycohemoglobin Standardization Program and the College of American Pathologists. b obtaining data from multiple certified methods does not ensure that data maintain maximum consistency. In the case of a biomarker such as HbA1c, an absolute bias in data collected across multiple testing platforms may mask a therapeutic effect or inappropriately support the expected outcome.

An abnormal laboratory test result does not confirm the presence of disease or a clinical condition. Similarly, a normal laboratory test result does not rule out disease. The sensitivity and specificity of the assay will change with the absolute value of the reported results. The plot of sensitivity versus specificity is known as a receiver operator curve (ROC). A significant literature has been published on the use of ROCs to optimize the diagnostic limits of laboratory and other biomarker tests [13].

Alternatively, having the site transfer a capillary of the specimen into the Bio-Rad preservative can stabilize the specimen for relatively long-term ambient or refrigerated handling [4]. Once a specimen is opened and processed at the site, the risk of improper identification Figure 1 Patient specimens were transported at ambient conditions to Covance Central Laboratory and analyzed the day after collection and additional analyses were performed after storage at the specified times and temperatures.

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