Biomedical Engineering Reference
In-Depth Information
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Guidelines
International Conference on Harmonisation of Technical Requirements for Registrations of
Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Validation of
Analytical Procedures: Text and Methodology, Q2(R1), Current Step 4 version, 2005, 13
pp. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
U.S. Food and Drug Administration CFR—Code of Federal Regulations Title 21, Part 58—Good
laboratory practice for nonclinical laboratory studies. http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=58
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