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Current Allergy and Asthma Reports

Erschienen in:

01.03.2016 | Immunologic/Diagnostic Tests in Allergy (M Chapman and A Pomés, Section Editors)

Standardization and Regulation of Allergen Products in the European Union

verfasst von: Julia Zimmer, Stefan Vieths, Susanne Kaul

Erschienen in: Current Allergy and Asthma Reports | Ausgabe 3/2016

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Abstract

Product-specific standardization is of prime importance to ensure persistent quality, safety, and efficacy of allergen products. The regulatory framework in the EU has induced great advancements in the field in the last years although national implementation still remains heterogeneous. Scores of methods for quantification of individual allergen molecules are developed each year and also the challenging characterization of chemically modified allergen products is progressing. However, despite the unquestionable increase in knowledge and the subsequent improvements in control of quality parameters of allergen products, an important aim has not been reached yet, namely cross-product comparability. Still, comparison of allergen product potency, either based on total allergenic activity or individual allergen molecule content, is not possible due to a lack of standard reference preparations in conjunction with validated standard methods. This review aims at presenting the most recent developments in product-specific standardization as well as activities to facilitate cross-product comparability in the EU.

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Titel: Standardization and Regulation of Allergen Products in the European Union
verfasst von: Julia Zimmer
Stefan Vieths
Susanne Kaul
Publikationsdatum: 01.03.2016
Verlag: Springer US
Erschienen in: Current Allergy and Asthma Reports / Ausgabe 3/2016
Print ISSN: 1529-7322
Elektronische ISSN: 1534-6315
DOI: https://doi.org/10.1007/s11882-016-0599-4

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Springer Medizin

Standardization and Regulation of Allergen Products in the European Union

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Intrakapsuläre Tonsillektomie gewinnt an Boden

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