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Tag: first-in-human studies

Phase I Clinical Trials: Safety, Dosage, and Early Human Studies

Posted on May 8, 2025 digi By digi

Phase I Clinical Trials: Safety, Dosage, and Early Human Studies Understanding Phase I Clinical Trials: Safety, Dosage, and First-in-Human Studies Phase I clinical trials are the critical first step in testing new treatments in humans. Focused primarily on safety and dosage, these studies provide the foundation for all subsequent clinical development. Understanding Phase I design…

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Clinical Trial Phases, Phase 1 (Safety and Dosage)

Phase 0 (Microdosing Studies) in Clinical Trials: A Comprehensive Guide

Posted on May 3, 2025 digi By digi

Phase 0 (Microdosing Studies) in Clinical Trials: A Comprehensive Guide Complete Guide to Phase 0 (Microdosing Studies) in Clinical Trials Phase 0, or microdosing studies, represents an innovative strategy in early drug development. Designed to expedite the drug evaluation process, Phase 0 trials involve administering extremely low doses of investigational compounds to human volunteers to…

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Clinical Trial Phases, Phase 0 (Microdosing Studies)

Quick Guide

  • Clinical Trial Phases
    • Preclinical Studies
    • Phase 0 (Microdosing Studies)
    • Phase 1 (Safety and Dosage)
    • Phase 2 (Efficacy and Side Effects)
    • Phase 3 (Confirmation and Monitoring)
    • Phase 4 (Post-Marketing Surveillance)
  • Regulatory Guidelines
  • Clinical Trial Design and Protocol Development
  • Good Clinical Practice (GCP) and Compliance
  • U.S. FDA Regulations

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