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First-in-Human to Proof-Of-Concept: Addressing Development Challenges and Accelerating Timelines
This Webinar is over
Date | Jul 12, 2016 |
Time | 01:00 PM EDT |
Cost | Free |
Online
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This webinar will present a set of case studies on:
- Integrated single and multiple ascending dose studies combining healthy volunteer and POC investigations
- Real-time adaptive GMP manufacturing to enable dose, formulation and product changes within a clinical protocol in response to emerging clinical data
- Continuous supply of clinical trial material (CTM) to global clinical sites post-Phase I, avoiding the need for tech transfer and scale up prior to Phase II
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