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Adequate quality is essential for any medicinal product to be eligible for marketing. Quality includes verification of the identity, content and purity of a medicinal product in combination with a specified production process and its control. Allergen products derived from natural sources require particular considerations to ensure adequate quality. Here, we describe key aspects of the documentation...
Background
The Italian severe/uncontrolled asthma (SUA) web‐based registry encompasses demographic, clinical, functional, and inflammatory data; it aims to raise SUA awareness, identifying specific phenotypes and promoting optimal care.
Methods
Four hundred and ninety three adult patients from 27 Italian centers (recruited in 2011‐2014) were analyzed.
Results
Mean age was 53.8 years. SUA patients...
Regulatory approaches for allergen immunotherapy (AIT) products and the availability of high‐quality AIT products are inherently linked to each other. While allergen products are available in many countries across the globe, their regulation is very heterogeneous. First, we describe the regulatory systems applicable for AIT products in the European Union (EU) and in the United States (US). For Europe,...
Background
The BSP090 project aims at establishing European Pharmacopoeia Reference Substances in combination with the corresponding ELISA methods for the quantification of major allergens in allergen products. Two sandwich ELISAs proved suitable for quantification of Bet v 1, the major birch pollen allergen, in preceding phases of BSP090.
Methods
Two Bet v 1‐specific ELISA systems were compared...
To cite this article: Brunetto B, Tinghino R, Braschi MC, Antonicelli L, Pini C, Iacovacci P. Characterization and comparison of commercially available mite extracts for in vivo diagnosis. Allergy 2010; 65: 184–190.
AbstractBackground: Assessment of sensitization by allergen‐specific IgE testing and skin prick testing (SPT) are primary tools in routine clinical diagnosis of allergies. To perform...
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