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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
guidelines concept paper on gene therapy concept paper on the development of a cpmp guideline on comparability of biotechnology-derived products
Last Update: 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
Last Update: 2011-10-23
Usage Frequency: 2
Quality:
Warning: This alignment may be wrong.
Please delete it you feel so.