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The Westin Boston Waterfront

Aug 13, 2018 8:00 AM - Aug 14, 2018 4:00 PM

425 Summer Street, Boston, MA 02210

New Drug Product Development and Lifecycle Management

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Module 3: Phase 1 – Initial Human Testing

Session Chair(s)

Stephen V. O'Quinn, PharmD

Stephen V. O'Quinn, PharmD

President

Perissos, Inc., United States

Objectives of Phase 1 Oncology Studies
Regulatory Requirements for First in Human Studies
Conducting Phase 1 Clinical Studies
Formulation Development during Phase 1
Toxicology Studies During Phase 1
End of Phase 1 Decision

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