Issue Date: July 1, 1996
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final
E4 Dose-Response Information to Support Drug Registration
Knowledge of the relationships among dose, drug concentration drug concentration in blood, and clinical response (effectiveness and undesirable effects) is important for the safe and effective use of drugs in individual patients. This information can help identify an appropriate starting dose, the best way to adjust dosage to the needs of a particular patient, and a dose beyond which increases would be unlikely to provide added benefit or would produce unacceptable side effects.
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