Lexic.us

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

Literary usage of Phase I clinical trial

Below you will find example usage of this term as found in modern and/or classical literature:

1. New Developments and Applications in Experimental Design: Selected by Nancy Flournoy, William F. Rosenberger, Weng Kee Wong (1998)
"The objective of a phase I clinical trial is to determine a maximum tolerated dose (MTD), where response is generally dichotomous ("toxicity" or "no ..."

2. Adaptive Designs: Selected Proceedings of a 1992 Joint Ams-Ims-Siam Summer by Nancy Flournoy, William F. Rosenberger, American Mathematical Society, Institute of Mathematical Statistics (1995)
"... response function is equal to the prior for (3 that was elicited by Flournoy (1994) for estimating optimal treatment levels in a phase I clinical trial. ..."

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