Transcription of ICH HARMONISED TRIPARTITE GUIDELINE
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ICH HARMONISED TRIPARTITE GUIDELINE
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL. REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. ICH HARMONISED TRIPARTITE GUIDELINE . THE CLINICAL EVALUATION OF QT/QTC INTERVAL. PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON- ANTIARRHYTHMIC DRUGS. E14. Current Step 4 version dated 12 May 2005. This GUIDELINE has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA. E14. Document History New First Codification History Date Codification November 2005.
(fatal and non-fatal) associated with the use of a drug have resulted in the withdrawal from the market of several drugs and relegation of other drugs to second-line status. Because prolongation of the QT/QTc interval is the ECG finding associated with the increased susceptibility to these arrhythmias, an adequate pre-marketing
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