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

Issue Date: May 5, 2003
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Final

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

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).

Download the Guidance Document

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