Comparison of allergenic extracts from different origins: the value of the FDA’s bioequivalent allergy unit (BAU)
Introduction: Allergy immunotherapy (AIT) is the only disease-modifying intervention for the treatment of allergic diseases. The clinical effectiveness of AIT is clearly dose-dependent, so it is important that clinicians can assess and compare the potency of the various products available. However,...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
30 May 2016
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| In: |
Expert review of clinical immunology
Year: 2016, Volume: 12, Issue: 7, Pages: 733-739 |
| ISSN: | 1744-8409 |
| DOI: | 10.1080/1744666X.2016.1187561 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1080/1744666X.2016.1187561 Verlag, Volltext: https://doi.org/10.1080/1744666X.2016.1187561 
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| Author Notes: | Giovanni Passalacqua, Joaquín Sastre, Oliver Pfaar, Ulrich Wahn, Pascal Demoly |
| Summary: | Introduction: Allergy immunotherapy (AIT) is the only disease-modifying intervention for the treatment of allergic diseases. The clinical effectiveness of AIT is clearly dose-dependent, so it is important that clinicians can assess and compare the potency of the various products available. However, this is not possible in practice, because manufacturers use different methods to determine potency. Therefore, a clear need exists for adoption of a ‘gold-standard’ measure of allergenicity. The bioequivalent allergy unit (BAU) is thus far the only allergen unit approved by a regulatory agency (the US Food and Drug Administration), with European regulatory authorities yet to adopt a common unit.Areas covered: Using PubMed, we performed a review of the literature on measures of allergen extract potency, use of the BAU, and BAU assessment for grass pollen tablets.Expert commentary: There is an obvious benefit to allergists and patients for having a single, comparable unit across products, and we strongly support the adoption of a single, ‘gold-standard’ unit of measurement for all products. Use of the BAU allows a clear comparison of the potency of allergen products from different manufacturers, and enables better understanding of the potential reasons for any differences in administration and dosing protocols between these products. |
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| Item Description: | Gesehen am 13.02.2019 |
| Physical Description: | Online Resource |
| ISSN: | 1744-8409 |
| DOI: | 10.1080/1744666X.2016.1187561 |