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ICH Topic: The draft ICH S7B step 2: Note for guidance on safety pharmacology studies for human pharmaceuticals

2002; Wiley; Volume: 16; Issue: 2 Linguagem: Inglês

10.1046/j.1472-8206.2002.00079.x

1472-8206

Gerd Bode, Klaus Olejniczak,

Poisoning and overdose treatments

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.