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Microdosing: Special Focus
Future Science Ltd, March 2010, Pages: 180
This Special Focus Issue of the peer-reviewed journal Bioanalysis on microdosing collates data and experience of experts and thought leaders in the field of drug discovery and development and places the microdosing concept into context with the rest of the discovery and development process. It includes overviews of the concept, examining how and when it can be most effectively applied with examples. Moreover, the different bioanalytical methods are critically examined, together with the validation of Accelerator Mass Spectrometry (AMS).
Indeed, AMS has applications beyond the normal definition of microdosing. Examples include biomarkers, PET, tissue level determination from small biopsy samples, analysis of free drug in microdialysates, simultaneous intravenous and oral absolute bioavailability studies and low radioactive dose ADME studies in humans.
This special issue provides a balanced view of microdosing and some of the associated strategies arising from the technologies, and allows for a more rational decision making process on the applicability to their particular programs and how to integrate such strategies, where appropriate, to successfully and more rapidly achieve drug registration, as was originally envisaged by the critical path initiative.
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