Phase I Trial
/ˈfeɪz wʌn traɪəl/
Definitions
- (n.) A preliminary clinical study conducted to assess the safety, dosage, and side effects of a new drug or treatment in a small group of human subjects, often involving legal compliance with regulatory requirements.
The company initiated a Phase I trial to evaluate the drug's safety before proceeding to later phases.
Forms
- phase i trial
- phase i trials
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Commentary
In legal contexts, Phase I trials are crucial for regulatory submissions and must comply with strict consent and safety standards to protect participants.
This glossary is for general informational and educational purposes only. Definitions are jurisdiction-agnostic but reflect terminology and concepts primarily drawn from English and American legal traditions. Nothing herein constitutes legal advice or creates a lawyer-client relationship. Users should consult qualified counsel for advice on specific matters or jurisdictions.