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Guidance for Industry:

Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology -Derived Pharmaceuticals S6(R1)(PDF - 160 KB - 15 páginas)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194490.pdf

Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Annex 11: Capillary Electrophoresis (PDF - 90 KB - 6 páginas)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194492.pdf General Chapter


Annex 12: Analytical Sieving General Chapter (PDF - 313 KB - 14 páginas)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM194501.pdf