By John Bloom, Richard A. Dean
Proposing functions in medical improvement, pharmacokinetic/ pharmacodynamic modelling and medical trial simulation, this reference experiences the position of biomarkers in profitable drug formula and improvement.
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Extra resources for Biomarkers in Clinical Drug Development (Drugs and the Pharmaceutical Sciences)
The information system is the key instrument providing timely access to data formatted to the needs of these end users. The reporting processes of the information system need to be sufﬁciently ﬂexible to address the requirements of the various users of the data. Personnel responsible for patient care need information organized in a way that helps them effectively evaluate the status of individuals in their care. By contrast, the protocol scientiﬁc personnel typically need study datasets so that they can evaluate drug response within and/or between study populations or population subsets.
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. Finally, the certiﬁcation program provides a network of analytical facilities to advance clinical research dependent upon key biomarkers.
Chem. 2000, 46, A39. Jensen, R. Preanalytical variables in the coagulation laboratory. Clin. Hemostas. Rev. 2001, 15, 1 – 4. S. ; Lexi-Comp: Hudson (Cleveland) OH, 1994; 149– 150. 30 Kapke and Dean 7. C. Self-collection by diabetic patients of capillary blood for free insulin monitoring: reduction by diamide of haemolysisinduced insulin loss. Diabetic Med. 1991, 8, 140– 145. S. ; AACC Press: Washington, DC, 1997. S. ; AACC Press: Washington, DC, 1997. S. ; AACC Press: Washington, DC, 2000; Vols.