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phase I clinical trial

   Also found in: Medical, Encyclopedia, Wikipedia, Hutchinson 0.01 sec.
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Noun1.phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
clinical test, clinical trial - a rigorously controlled test of a new drug or a new invasive medical device on human subjects; in the United States it is conducted under the direction of the FDA before being made available for general clinical use


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If a new treatment is found to be reasonably safe in phase I clinical trials, the treatment can then be tested in a phase II clinical trial to see if it works the way researchers think it will.
The July-dated document, "Guidance for Industry: GMP for Phase I Investigational Drugs" represents FDA's current viewpoint on the application of GMPs to Phase I clinical trial drugs.
Cambridge, MA, announced the FDA has placed a clinical hold on the company's Phase I clinical trial evaluating CB001, an investigational cord blood stem cell product for hematopoietic stem cell transplantation in patients affected by a variety of cancers.
 
 
 
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