Usted buscó: comparability (Neerlandés - Inglés)

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Neerlandés

note for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substance

Inglés

note for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substance

Última actualización: 2011-10-23
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Neerlandés

such comparability is requested by all users , not only at community level , but also within member states .

Inglés

such comparability is requested by all users , not only at community level , but also within member states .

Última actualización: 2011-10-23
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Neerlandés

the regulation defines a set of relevant statistical data , together with the most important definitions needed to ensure the comparability of the statistics .

Inglés

the regulation defines a set of relevant statistical data , together with the most important definitions needed to ensure the comparability of the statistics .

Última actualización: 2011-10-23
Frecuencia de uso: 1
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Neerlandés

concept-rapporten concept paper on gene therapy concept paper on the development of a cpmp guideline on comparability of biotechnology-derived products

Inglés

guidelines concept paper on gene therapy concept paper on the development of a cpmp guideline on comparability of biotechnology-derived products

Última actualización: 2011-10-23
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Neerlandés

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 .

Inglés

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 .

Última actualización: 2011-10-23
Frecuencia de uso: 1
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Neerlandés

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

Inglés

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

Última actualización: 2011-10-23
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Neerlandés

note for guidance on pharmacokinetic studies in man points to consider on live-attenuated influenza vaccines guidance on requirements for pharmaceutical/clinical documentation for cell culture influenza vaccines points to consider on xenogeneic cell therapy note for guidance on comparability of medicinal products containing biotechnology-derived proteins as active substance note for guidance on the use of medicinal products during pregnancy: need for post-marketing data note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling revision of the note for guidance on harmonisation of requirements for influenza vaccines

Inglés

note for guidance on pharmacokinetic studies in man points to consider on live attenuated influenza vaccines guidance on requirements for pharmaceutical/ clinical documentation for cell culture influenza vaccines points to consider on xenogeneic cell therapy note for guidance on comparability of medicinal products containing biotechnology-derived proteins as active substance note for guidance on the use of medicinal products during pregnancy: need for post-marketing data note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling revision of the note for guidance on harmonisation of requirements for influenza vaccines

Última actualización: 2011-10-23
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Neerlandés

section ii (pharmacokinetic and clinical evaluation) on the clinical requirements of modified release products submitted as a line- extension of an existing marketing authorisation points to consider on xenogenic cell therapy note for guidance on comparability of medicinal products containing biotechnology- derived proteins as active substance note for guidance on the use of medicinal products during pregnancy note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling

Inglés

points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population note for guidance on the evaluation of the pharmacokinetics of

Última actualización: 2011-10-23
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Neerlandés

titel document position paper on the non-clinical safety studies to support clinical trials with a single low dose of a compound note for guidance on specification limits for residues of metal catalysts note for guidance on comparability of medicinal products containing biotechnology-derived proteins as drug substance:

Inglés

medicinal products in patients with hepatic impairment note for guidance on clinical investigation of medicinal products

Última actualización: 2011-10-23
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Neerlandés

‘ points to consider on live-attenuated influenza vaccines’ ‘ points to consider on cumulative stability requirements for vaccines’ ‘ concept paper on requirements for evaluation of new immunological ’ adjuvants’ in vaccines’ ‘ note for guidance on comparability r-dna-derived medicinal products’ (samen met de werkgroepen werkzaamheid en veiligheid)

Inglés

note for guidance on immune sera of animal origin points to consider on human somatic cell therapy products (jointly with efficacy and safety working parties)

Última actualización: 2011-10-23
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