By John Bloom, Richard A. Dean
Offering purposes in scientific improvement, pharmacokinetic/ pharmacodynamic modelling and scientific trial simulation, this reference experiences the function of biomarkers in profitable drug formula and improvement.
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Additional info for Biomarkers in Clinical Drug Development (Drugs and the Pharmaceutical Sciences)
13. 14. 3 Using Imaging Biomarkers to Demonstrate Efﬁcacy in Clinical Trials: Trends and Challenges Charles G. A. A. I. EVOLUTION OF IMAGING BIOMARKERS FOR CLINICAL TRIALS Interest in imaging biomarkers and their use in clinical trials has literally exploded over the past several years. This is evidenced by the proliferation of symposia and scientiﬁc conferences around the world that focus on this topic. The National Institutes of Health and various international societies have formed committees and launched ambitious initiatives to promote the area and advance knowledge about the use of imaging biomarkers in clinical research.
Documentation of the performance of the “average of normals” in the clinical laboratory has been used to demonstrate consistent assay performance and has been utilized as a quality control process . The “average of normals” concept has been demonstrated to be beneﬁcial in the routine clinical laboratory and has the same potential in a biomarker laboratory with appropriate knowledge of the dynamics of the population of samples being analyzed. Even when appropriate standards are available one needs to be sensitive to the manufacturer’s tolerances in standard assignment.
The technical challenge in all of these morphological assessments is edge detection and image segmentation. These depend on spatial resolution and image contrast between the structure of interest and background tissue, and both of these image parameters in turn depend on the details of the acquisition technique used. Therefore, success in morphological image analysis requires sophistication and experience in designing imaging protocols as well as a clear understanding of how different protocol decisions will affect the measurement algorithm to be used (Figs.
Biomarkers in Clinical Drug Development (Drugs and the Pharmaceutical Sciences) by John Bloom, Richard A. Dean