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.
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:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.