lunes, 5 de abril de 2010

Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions


Guidance for Industry:Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
Annex 7:Dissolution Test General Chapter (PDF - 93 KB)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm085366.pdf

Annex 9: Tablet Friability General Chapter (PDF - 84 KB)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM176888.pdf

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