First-In-Human Studies: Science-Driven Strategies
Thursday, October 23rd, 2008 - On Demand Archive now available
Speakers for this Event:
- Todd Johnson, MD, Senior Vice President, Early Stage Development, MDS Pharma Services
- Robert F. Butz, PhD, Vice President, Medical & Scientific Affairs, Biovail
- Michelle L. Combs, PhD, Vice President, Global Clinical Pharmacology, MDS Pharma Services
- Gaetano Morelli, MD, Senior Director, Global Medical Affairs, MDS Pharma Services
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Attend this free interactive webcast and learn about science-driven strategies for a successful First-in-Human trial including:
- “Timing” of clinical conduct
- Pros and cons of combined SAD/MAD designs
- Dose proportionality assessment in the planning of studies
- Mitigating risk
- Regulatory aspects, challenges and expectations
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