Jianguo Li to Speak at 3rd Pharmacokinetics & Pharmacodynamics Conference - Oct 24-26, 2012, PA

Top Quote Jianguo Li, Director & Senior Principal Scientist, Clinical Pharmacology at Astrazeneca Will Give a Featured Presentation on "Prediction of the Outcome of a Thorough QT study by PK/PD modeling - Issues for consideration" at the 3rd Pharmacokinetics & Pharmacodynamics Conference (Oct 24-26, 2012 in Philadelphia, PA) End Quote
  • (1888PressRelease) September 21, 2012 - Drug-induced QT interval prolongation is related to the risk of life-threatening ventricular arrhythmias. The E14 guidance recommends a highly controlled, rigorous clinical study, referred to as the "thorough QT/QTc (TQT)" study, to evaluate the potential of QT interval prolongation of new therapeutics. A positive TQT study may result in a termination of the development project or more intensive cardiac safety monitoring for future clinical development. It has been proposed to use the data of phase I clinical pharmacological studies, such as single ascending dose (SAD) studies, multiple ascending (MAD) dose studies to conduct a PK/PD modeling, and apply the model to predict the results of the TQT study. Dr. Jianguo Li will address the issues that need to be considered to use such an approach to predict the potential of QTc interval prolongation for an investigational product.

    Overview of TQT study in drug development
    ICH E14 biostatistical approach vs PK/PD modelling approach to conclude a positive QT study
    PK/PD modelling point of view to evaluate QT/QTc interval prolongation in the presence of drug induced change in heart rate
    The effect of ignoring diurnal change on the false positive and negative rate of TQT study with PK/PD modelling
    The effect of ignoring hysteresis on the false positive and negative rate of TQT study with PK/PD modelling

    Dr. Li is currently a Senior Principal Scientist, Senior Pharmacometrician and Director at the Clinical Pharmacology & Pharmacometics of AstraZeneca, and has been conducting research on the use of PK/PD modelling, population PK/PD modelling and clinical trial simulation approaches to help dose selection, efficacy and safety assessment for all phases of drug development in many therapeutic areas including cardiovascular, anit-infection and oncology. Dr. Li has made significant contributions to the use of PK/PD modelling approach to help to design and analyze QT interval prolongation and cardiac safety for thorough QT studies, etc.

    The 3rd Pharmacokinetics & Pharmacodynamics Conference is exclusively designed to showcase the state-of-the-art methodologies in the field of PK/PD, which would define the future of the field, and maximize the probability of achieving clinical success for drug companies. Key challenges faced by a PK/PD scientist will be addressed and approaches to overcome the challenges will be demonstrated.

    This conference is a part of our 8th Modern Drug Discovery & Development Summit, which includes five concurrent tracks including:

    Track: 3rd Pharmacokinetics & Pharmacodynamics
    Track: 9th Stem Cell Research & Therapeutics
    Track: 7th Assay Development & Drug Discovery
    Track: 4th Translational Medicine
    Track: Biotechnology Transfers & Commercialization

    For more information, please visit www.gtcbio.com

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