| Document Date: 2012-06-22 05:11:35
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Company ICH Expert Working Group / / Country Japan / United States / / IndustryTerm chemical change / unspecified degradation product / individual degradation products / unidentified degradation products / manufacturing experience / given degradation product / drug product / specified degradation product / individual degradation product / herbal products / certain new drug products / specified degradation products / normal manufacturing variations / fermentation products / chemical entity / reaction products / specified and unspecified degradation products / individual new drug products / registration applications / degradation product / specified unidentified degradation products / biological/biotechnological products / manufacturing practice / identified degradation product / crude products / unidentified degradation product / degradation products / drug products / normal manufacturing / isolated degradation products / semi-synthetic products / manufacturing process / / Organization European Union / / Position representative / batches representative / / Product R2 / R1 / / Technology radiopharmaceuticals / /
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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE