Phase I
Phase I
Phase I (pronounced: /feɪz wʌn/) is the first stage in the process of clinical trials for new drugs or treatments. The term originates from the Latin phasus, meaning "stage" or "phase", and the Roman numeral I, signifying the first stage.
Definition
In the context of clinical research, Phase I refers to the initial introduction of an investigational new drug into humans. These studies are closely monitored and are usually conducted in a small number of healthy volunteers (20 to 100). The primary purpose of Phase I trials is to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness.
Related Terms
- Clinical Trials: Research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention.
- Investigational New Drug (IND): A new drug that is in the process of being tested for safety and efficacy.
- Pharmacology: The branch of medicine concerned with the uses, effects, and modes of action of drugs.
- Metabolism: The chemical processes that occur within a living organism in order to maintain life.
- Side Effects: Unwanted or unexpected symptoms or feelings that occur when you take medicine.
Etymology
The term "Phase I" comes from the Latin phasus, meaning "stage" or "phase", and the Roman numeral I, signifying the first stage. In the context of clinical trials, it refers to the first stage of testing in human subjects.
Pronunciation
Phase I is pronounced as /feɪz wʌn/.
External links
- Medical encyclopedia article on Phase I
- Wikipedia's article - Phase I
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