ICH topic: the draft ICH S7B step 2: note for guidance on safety pharmacology studies for human pharmaceuticals.
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.
Bode
Gerd
G
Byk Gulden Pharmazeutika, Institut für pothologie und Toxikologie, Friedrich-Ebert-Damm 101, D-22047, Hamburg, Germany. Gerd.Bode@byk.de
Olejniczak
Klaus
K
D000818:Animals; D004334:Drug Administration Schedule; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000592:standards*; D015507:Drugs, Investigational / Q000009:adverse effects*; D004594:Electrophysiology / Q000379:methods; D008133:Long QT Syndrome / Q000139:chemically induced; D010601:Pharmacology, Clinical / Q000379:methods / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017180:Tachycardia, Ventricular / Q000139:chemically induced; D013678:Technology, Pharmaceutical / Q000592:standards*; D016171:Torsades de Pointes / Q000139:chemically induced
D015507:Drugs, Investigational