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E4 Dose-Response Information to Support Drug Registration July 1996

Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research

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.

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.