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Leveraging a Multiphase QT Strategy to Expedite Development and Reduce Investment Risk: Cost Effective Design, Execution and Analysis

Wednesday, November 5th, 2008 - On Demand Archive now available

    Speakers for this Event:
    • William Wheeler, MD, FACC,  Global Medical Director, Centralized Cardiac Services, MDS Pharma Services 

    • Michelle L. Combs, PhD,  Vice President, Global Clinical Pharmacology, MDS Pharma Services 

    • Nathan S. Teuscher, PhD,  Director, PK/PD, MDS Pharma Services 

    • Joy Olbertz, PharmD, PhD,  Director, Cardiac Safety Services, MDS Pharma Services 
      Sponsored by:
    MDSPharma Logo

Satisfactory completion of a Thorough QT/QTc Study (TQTS) is a requirement of nearly every new compound. By developing a QT strategy early in a compound lifecycle, drug developers can reduce investment risks and set the platform for cost effective trial planning and execution.

Intensive ECG monitoring in early stage studies, also known as a QT Intensive or Robust QT study, is a powerful tool for drug developers in anticipation of a TQTS and is often done in single ascending dose or multiple ascending dose studies.  This allows for earlier drug development decisions and potential cost savings when planning and executing the TQTS. Robust QT-type designs also allow QT assessment of toxic compounds, such as cytotoxic agents, that can not be administered to healthy volunteers.   

Leveraging the appropriate methodologies early can limit the financial risks associated with later development phases and provide critical data for protocol planning and execution.

 

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If you require help with your registration or have any questions you may contact Xtalks at: email: register@xtalks.com; phone: 416-977-6555, x 374.

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Early Stage Robust QT as an evaluation tool
Planning a cost effective QT strategy
FDA requirements for Thorough QT/QTc Study (TQTS)
Efficiency in study designs: Crossover, parallel and other designs
Operational efficiencies of a QT Strategy
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