Combining Technology and PK/PD Expertise to Optimize Drug Development:
A New Era for Collaborative Environments in Translational Medicine
Developing a new drug remains a costly and risky endeavor. In today’s challenging economic climate, at a time when development costs and timelines continue to skyrocket, effective use of technology, collaborative environments with multiple vendors and scientific expertise can help sponsors save money and shorten the overall development process for new drug approval.
This webinar will introduce integrated approaches for data management, PK/PD analysis, reporting technology and automation to optimize drug development. Collaborative platforms for efficient translational medicine activities will also be presented.
Through a series of case studies, this webinar will provide an overview of approaches and tools used by Pharsight in the drug development process for:
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Preclinical analysis and modeling to support first-in-human dose selection
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Phase I/II study analysis and reporting to support efficient protocol design
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Population PK/PD modeling to support program decision-making
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Regulatory submissions, CDISC and data transfer
The case studies will be supplemented with data and insights from drug development organizations on challenges and opportunities for efficient clinical study design, execution and analysis.