FDA Guidance for Industry: Q8(R2) Pharmaceutical Development Revision 2
Title:
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