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

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

https://www.gmp-compliance.org/files/guidemgr/9041fnl[1].pdf

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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