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.
FDA Guidance for Industry: Q8(R2) Pharmaceutical Development Revision 2
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073507.pdf
Content:
This guidance is an annex to ICH Q8 Pharmaceutical Development and provides further clarification of key concepts outlined in the core guideline
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