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

By John Bloom, Richard A. Dean

Featuring purposes in medical improvement, pharmacokinetic/ pharmacodynamic modelling and medical trial simulation, this reference reports the position of biomarkers in profitable drug formula and improvement.

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Sample text

Moreover, the potential role that imaging could play in clinical trials is the same role it currently plays in clinical practice, namely patient selection (diagnosis and staging), monitoring disease progression and treatment response, and assessing complications of therapy. What is, perhaps, difficult to understand is why 31 32 Peterfy and Maley the interest in imaging for clinical trials took so long to develop, as it has only been in the last several years that drug development has benefited substantively from these powerful tools.

In a high-throughput automated facility, the laboratory must have a process where critical patient safety information is conveyed directly to the caregiver with positive confirmation that the information was received. By providing realtime feedback through the reporting process, the clinical laboratory becomes an essential communication link in successful biomarker data delivery. The reliable delivery of laboratory test results and associated flagged results is a critical element ensuring patient/subject safety.

Delay in transit can result in specimens being received in a degraded condition. Effective tracking can allow for interventions like adding additional dry ice to delayed shipments. Analytical data are of value only if correctly associated with demographic data. The clinical laboratory has experience and systems to ensure that the essential demographic data are correctly captured. Collection devices and Clinical Laboratory 15 transport containers need to be linked to the patient in a robust manner.

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