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Downloads
EMEA: CPMP
The Assessment of the Potential for QT Intverval Prolongation by
Non-Cardiovascular Medicinal Products
EMEA_CPMP_Dec1997.pdf (55KB)

FDA:
Guidance for Industry, part 11; Electronic Records; Electronic
Signature - Scope and Application
FDA_part11_Sep2003.pdf (220KB)

ICH:
The Clinical Evaluation of the QT/QTc Interval Prolongation and
Proarrythmic Potential for Non-antiarrythmic Drugs
ICH_E14_June2004.pdf (240KB)