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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Guidance for Industry
Exposure-Response Relationships — Study
Design, Data Analysis, and Regulatory
Applications |
| Internet: | http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072109.pdf |
| Origin/Publisher: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ |
| Content: | 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. |
| Document Type: | Guidance for Industry |
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