Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development
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چکیده
منابع مشابه
Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development
A number of drivers and developments suggest that microdosing and other phase 0 applications will experience increased utilization in the near-to-medium future. Increasing costs of drug development and ethical concerns about the risks of exposing humans and animals to novel chemical entities are important drivers in favor of these approaches, and can be expected only to increase in their releva...
متن کاملPhase 0 - Microdosing strategy in clinical trials
Drug development is an activity that is long, complex and expensive. In 2004, attrition in the drug development paradigm prompted the US Food and Drug Administration (FDA) to introduce its 'Critical Path' document, which highlighted the serious discordance between major scientific advances and limited drug development process. One issue addressed was that of microdosing. The concept of microdos...
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Recent guidance from the US Food and Drug Administration supports the conduct of a new type of exploratory clinical trials, commonly called phase 0 clinical trials, on the development of innovative anticancer agents, particularly targeted agents. Phase 0 clinical trials are controversial mainly because of the lack of clinical benefit to the participant patients. However, it was recognized that ...
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Phase 0 trials are designed primarily to evaluate the pharmacodynamic and/or pharmacokinetic properties of selected investigational agents before initiating more traditional phase I testing. One of the major objectives of phase 0 trials is to interrogate and refine a target or biomarker assay for drug effect in human samples implementing procedures developed and validated in preclinical models....
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while preclinical research answers basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body. “clinical research” refers to studies, or trials, that are done in people 1,2. as the developers design the clinical study, they will consider what they want to accomplish for each of the different clinical research phases and begin the...
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ژورنال
عنوان ژورنال: Clinical and Translational Science
سال: 2016
ISSN: 1752-8054
DOI: 10.1111/cts.12390