Phase I clinical trials
Phase I Clinical Trials
Phase I clinical trials (pronunciation: /feɪz wʌn klɪnɪkəl traɪəlz/) are the first stage of testing in human subjects, designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug or treatment.
Etymology
The term "Phase I" originates from the Food and Drug Administration (FDA)'s process of drug approval, which is divided into different phases. The "I" is a Roman numeral representing the first stage of this process.
Description
Phase I trials are often conducted in small groups of healthy volunteers. The primary aim is not to test the efficacy of the new drug, but to evaluate its safety profile and determine the dosage range that can be used in future studies. These trials also help to identify any side effects and how the drug is metabolized and excreted.
Related Terms
- Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects on health outcomes.
- Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and excreted by the body.
- Pharmacodynamics: The study of the biochemical and physiological effects of drugs and their mechanisms of action.
- Phase II Clinical Trials: The second phase of clinical trials, which focuses on the effectiveness of the drug and further evaluates its safety.
- Phase III Clinical Trials: The third phase of clinical trials, which involves randomized and blind testing in several hundred to several thousand patients.
See Also
External links
- Medical encyclopedia article on Phase I clinical trials
- Wikipedia's article - Phase I clinical trials
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