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First-in-man trials: Revision history

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3 June 2025

27 March 2025

  • curprev 14:1014:10, 27 March 2025 Lawrence talk contribs 5,262 bytes −1 No edit summary
  • curprev 14:0814:08, 27 March 2025 Lawrence talk contribs 5,263 bytes 0 No edit summary
  • curprev 14:0614:06, 27 March 2025 Lawrence talk contribs 5,263 bytes +5,263 Created page with "= First-in-man trials = A '''First-in-Man (FIM) trial'''—also known as a '''First-in-Human (FIH) trial'''—is the first clinical study in which a new investigational drug, biologic, or medical device is administered to human participants. These trials follow extensive preclinical testing and are typically classified as Phase 1 trials. The primary focus of FIM trials is to assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) before proceeding..."
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