International Conference on Harmonization
This article was originally published in The Tan Sheet
ICH Steering Committee endorses seven final tripartite guidelines at an Oct. 26-27 meeting in Brussels, Belgium. The guidelines, which will be published in a future issue of the Federal Register, are: Extent of Population Exposure to Assess Clinical Safety; Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; Good Clinical Practices: Addendum on Essential Documents; Validation of Analytical Methods: Definitions and Terminology; Guidance for Dose Selection for Carcinogenicity Studies: and Guidance for Repeated Dose Tissue Distribution Studies
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