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GUIDANCE DOCUMENT

Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications May 2003

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2002-D-0177
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This document provides recommendations for sponsors of investigational new drugs (INDs) and applicants submitting new drug applications (NDAs) or biologics license applications (BLAs) on the use of exposure-response information in the development of drugs, including therapeutic biologics. It can be considered along with the International Conference on Harmonisation (ICH) E4 guidance on Dose-Response Information to Support Drug Registration and other pertinent guidances (see Appendix A).

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All written comments should be identified with this document's docket number: FDA-2002-D-0177.

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