As seen in IPI (International Pharmaceutical Industry) magazine. Japan's Pharmaceuticals and Medical Devices Agency (PMDA) recently implemented ICH Guideline E14, an important regulatory concern for companies aiming to market their drugs in that country. Already adopted by the US, Europe and Canada, ICH E14 requires safety data using the Thorough QT/QTc study to identify potentially excessive risk of drug-induced proarrhythmia. Quintiles' Dr. Rick Turner reviews the implications of this development, including questions on how ethnicity may impact cardiac adverse drug reactions.
White Paper December 06, 2010