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note for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substance
note for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substance
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such comparability is requested by all users , not only at community level , but also within member states .
such comparability is requested by all users , not only at community level , but also within member states .
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the regulation defines a set of relevant statistical data , together with the most important definitions needed to ensure the comparability of the statistics .
the regulation defines a set of relevant statistical data , together with the most important definitions needed to ensure the comparability of the statistics .
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concept-rapporten concept paper on gene therapy concept paper on the development of a cpmp guideline on comparability of biotechnology-derived products
guidelines concept paper on gene therapy concept paper on the development of a cpmp guideline on comparability of biotechnology-derived products
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community legislation on statistics on the structure and activity of foreign affiliates is needed to set common statistical standards for data , with a high degree of comparability between data colleted in different member states .
community legislation on statistics on the structure and activity of foreign affiliates is needed to set common statistical standards for data , with a high degree of comparability between data colleted in different member states .
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63) note for guidance on photosafety testing; points to consider document on the need for assessment of reproductive toxicity in the development of human insulin analogues discussion paper on environmental risk assessments of non-gmo containing medicinal products for human use non-clinical documentation of medicinal products with ‘ well-established use’ note for guidance on the need for non-clinical testing of pharmaceuticals in juvenile animals discussion paper on the non-clinical safety studies to support single low dose clinical screening studies in man note for guidance on specification limits for residues for heavy metal catalysts in medicinal products points to consider on xenogeneic cell therapy note for guidance on comparability of biotechnology products pre-clinical and clinical issues points to consider on the assessment of the potential for qt interval prolongation by non-cardiovascular medicinal products note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling
63) note for guidance on photosafety testing points to consider document on the need for assessment of reproductive toxicity of human insulin analogues discussion paper on environmental risk assessments of non-gmo containing medicinal products for human use non-clinical documentation of medicinal products with ‘ well-established use’ note for guidance on the need for non-clinical testing of pharmaceuticals in juvenile animals discussion paper on the non-clinical safety studies to support single low dose clinical screening studies in man note for guidance on specification limits for residues for heavy metal catalysts in medicinal products points to consider on xenogeneic cell therapy note for guidance on comparability of biotechnology products pre-clinical and clinical issues
Последнее обновление: 2011-10-23
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