Zdrowie i gospodarka · 2.04.2002
Draft Guidance for Industry on Exposure-Response Relationships: Study Design, Data Analysis, and Regulatory Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Exposure- Response Relationships: Study Design, Data Analysis, and Regulatory Applications." The guidance is intended to provide recommendations for sponsors of investigational new drug applications (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.