Presentation on S7A - ICH
Presentation on S7A - ICH
Presentation on S7A - ICH
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General C<strong>on</strong>siderati<strong>on</strong> in Selecti<strong>on</strong><br />
and Design<br />
• Therapeutic class (e.g. proarrhythmia of antiarrhythmic<br />
agents)<br />
• Members of the chemical or therapeutic class but<br />
independent of primary PD effects (e.g. anti-psychotics<br />
and QT prol<strong>on</strong>gati<strong>on</strong>)<br />
• Ligand binding or enzyme assay<br />
• Results from Previous SP, sec<strong>on</strong>dary PD, tox studies, or<br />
from human use<br />
• Hierarchy: life-supporting system (CNS, CVS, Resiratory)<br />
Other organ systems when c<strong>on</strong>sidering factors, e.g.,<br />
clinical trial or patient populati<strong>on</strong><br />
<strong>ICH</strong>-5 November 10, 2000
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