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Module 4: Phase 2 – Preliminary Human Efficacy and Safety
Session Chair(s)
Stephen V. O'Quinn, PharmD
President
Perissos, Inc., United States
- Objectives of Phase 2
- Regulatory Activities and Expedited Programs
- Drugs for Orphan and Life-Threatening Diseases
- Clinical Development and Biostatistics Activities
- Formulation Development in Phase 2
- Toxicology Studies in Phase 2
- Risk Return Decisions in Phase 2
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