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Examples
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The current drug approval system doesn't yet acknowledge the superiority of human-focused, nonanimal research methods (such as microdosing) and all pharmaceutical companies must use animals to get their drugs approved.
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The journal also included a perspective written by a pair of Johns Hopkins researchers - Thomas Kensler and John Groopman - who praise the methodology and suggest that these Phase 0 "microdosing" studies should be expanded.
R&D Mag - News 2009
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"With microdosing, they don't invest much and that reduces their risk," Tabo said.
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"There is no guarantee for those who play with the system, even those doing so thinking that they are getting away with microdosing," he insisted.
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BMC Racing Team rider Thomas Frei recently tested positive for EPO and claimed that he would have beaten the test for his microdosing had he drunk enough water after taking the injection.
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Quotient offers its clients a unique service that combines the manufacture of custom radiolabelled drug compounds; a full range of in vivo and in vitro metabolism studies covering all FDA guidelines; clinical studies, including Human AME studies, ivMicrotracerTM, and Phase 0 microdosing studies; and a broad range of bioanalytical services.
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Yet microdosing on human volunteers would have detected the problem without requiring testing on primates, Ms Creamer argues.
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They wrote: "… microdosing studies with carcinogens have the potential to provide important insights into chemopreventive interventions and to enhance the overall clinical development and safety evaluation of preventive agents."
R&D Mag - News 2009
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Coca-Cola Freestyle is the brand name for the "fountain of the future" from Coca-Cola (NYSE: KO) that uses microdosing technology to dispense more than 100 sparkling and still beverage brands from a single freestanding unit.
National Business News - Local Business News | bizjournals 2009
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In a human microdosing study the compound was extremely well absorbed, demonstrated good bioavailability and had a half-life that appears compatible with once-a-day oral dosing.
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