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cpmp biotechnology working party
grupo de trabajo del cpmp “ biotecnología”
最后更新: 2012-04-10
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roche diagnostics gmbh, pharma biotechnology production nonnenwald 2 82372 penzberg germania
roche diagnostics gmbh, pharma biotechnology production nonnenwald 2 82372 penzberg alemania
最后更新: 2011-10-23
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abbott biotechnology deutschland gmbh max-planck-ring2 d-65205 wiesbaden no
na responsable de la fabrica ción abbott biotechnology deutschland gmbh max-planck-ring 2
最后更新: 2011-10-23
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abbott biotechnology deutschland gmbh max-planck-ring 2 d-65205 wiesbaden germania
abbott biotechnology deutschland gmbh max-planck-ring 2 d-65205 wiesbaden alemania
最后更新: 2011-10-23
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abbott biotechnology deutschland gmbh au max-planck-ring 2 d-65205 wiesbaden germania iù b.
na abbott biotechnology deutschland gmbh max-planck-ring 2 d-65205 wiesbaden alemania
最后更新: 2011-10-23
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documento concettuale concept paper on gene therapy concept paper on the development of a cpmp guideline on comparability of biotechnology-derived products
concept paper on gene therapy concept paper on the development of a cpmp guideline on comparability of biotechnology- d e r ived products
最后更新: 2011-10-23
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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 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 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
最后更新: 2011-10-23
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