Toronto, Canada (PRWEB) September 12, 2012
This webinar will provide best practice insights into dose selection for First in Human (FIH) dose escalation studies to mitigate risk and optimize the value of your early clinical data: To explore key considerations from protocol design and bioanalysis strategy to pharmacokinetic-pharmacodynamic (PK-PD) modeling and simulation technique using illustrative scenarios.
With increasing R&D costs and declining industry success in getting products to market, pharmaceutical companies need to maximize the knowledge that can be gleaned from early Phase I/IIa study data to make better go/no-go decisions and improve success in late stage development.
Identifying the best dose escalation scheme in FIH dose escalation studies is a critical and often underestimated step in early development decision-making. Likewise, setting up ideal study collection procedures is key to getting the most out of the subject data to efficiently produce an accurate understanding of your compound’s strengths and susceptibilities. This webinar will explore ways to optimize study design, from sampling plans to adjusting dose escalation based on tolerability and PK-PD during the course of the study to ultimately improve the value of the data at Proof of Concept.
This webinar will examine:
- How to design FIH for the most efficient and valuable dose escalation strategy
- Understanding critical bioanalysis considerations to ensure data will support decision making and regulatory requirements
- Modeling and Simulation to pull together the data and determine what the next treatment arm should be
The webinar will offer an understanding of ways to make the most of early clinical development -- from efficiently conducting studies safely and obtaining reliable bioanalytical data, to providing dependable model predictions to optimize the overall process. These key factors in early drug development significantly influence the overall success or failure of compounds, and ultimately return on investment.
For more information or to register go to http://xtks.in/xto-510
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.
To learn more about Xtalks visit http://xtalks.com/ContactUs.ashx
Karen Lim (416) 977-6555 ext 227