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GUIDANCE DOCUMENT

E4 Dose-Response Information to Support Drug Registration July 1996

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-1993-D-0183
Issued by:
Guidance Issuing Office
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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

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

All written comments should be identified with this document's docket number: FDA-1993-D-0183.

 
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