Definition of Phase I clinical trial
1. Noun. 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.
Medical Definition of Phase I clinical trial
1.
The earliest stage clinical trial for studying an experimental drug in humans. Phase I trials are generally comparatively small and are used to determine toxicity and maximum dose.
They provide an initial evaluation of a drug's safety and pharmacokinetics-how the drug is absorbed, what tissues it reaches and how long it takes to leave the body. Such studies also usually test various doses of the drug (dose-ranging) to obtain an indication of the appropriate dose to use in later studies.
The patients in these trials usually have advanced disease and have already received best available chemotherapy, therefore, seeing a repose is significant partially because this means there is a lack of cross-resistance between two anti-cancer drugs.
(31 Dec 1997)
Lexicographical Neighbors of Phase I Clinical Trial
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