Event Date/Time: May 28, 2012
End Date/Time: May 29, 2012
Pharmaceutical companies applying for new drug approval in Japan are now required to satisfy the ICH-E14 guideline. The hallmark of the ICH-E14 guidance is the Thorough QT (TQT) Study, or its alternatives for drugs that do not lend themselves to the E14 TQT paradigm. While experience in conducting and analyzing TQT studies in Japan is rapidly developing, many issues remain open. Some of these issues include the potential for ethnic differences in QT pharmacodynamics, the need to extrapolate QT data from foreign studies into Japanese subjects, the use of positive control, advanced study designs and methods for concentration - effect modelling, etc. The 3rd Cardiac Safety Workshop in Japan will explore these topics and others, including those listed in the program. The program committee would like to invite authors to submit abstracts for oral presentation for review.
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