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ICH topic: the draft ICH S7B step 2: note for guidance on safety pharmacology studies for human pharmaceuticals
1Byk Gulden Pharmazeutika, Institut für pothologie und Toxikologie, Friedrich-Ebert-Damm 101, D-22047, Hamburg, Germany. Gerd.Bode@byk.de
Abstract:
During the last ICH Expert Working Group meeting for Safety Pharmacology in February 2002 in Brussels, the appended step 2 S7B document on QT Prolongation was signed off. This paper will now be published by the three agencies. The comment period will be 6 months. Nevertheless, the EU and EFPIA would be very appreciative of comments received before the end of May 2002, in order to start the discussion on how this step 2 document should be modified. In addition, everybody is requested to share data that could support the evaluation process of all methods addressed in this document. The EWG appreciates every support.