A Review on: Phase ‘0’ Clinical Trials or Exploratory Investigational New Drug
نویسندگان
چکیده
منابع مشابه
Leveraging exploratory investigational new drug studies to accelerate drug development.
In 2006, the U.S. Food and Drug Administration published its guide on exploratory investigational new drug (IND) studies with the goal of making the approach to early-stage, pilot clinical trials more flexible within the context of current regulations. The exploratory IND allows sponsors to initiate clinical trials of limited scale with reduced preclinical requirements. These studies may be imp...
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Phase 0 clinical trials are considered first-in-human studies that require extensive agent characterization and target assay development before administration. Phase 0 clinical trial goals can include assessing the pharmacokinetic-pharmacodynamic relationships of an investigational drug. They cover the rational transition from preclinical to clinical drug development, which includes an assessme...
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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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ژورنال
عنوان ژورنال: Turkish Journal of Pharmaceutical Sciences
سال: 2017
ISSN: 1304-530X,2148-6247
DOI: 10.4274/tjps.63935