Standardization of allergen products: 3. Validation of candidate European Pharmacopoeia standard methods for quantification of major birch allergen Bet v 1-Reference-Cited by-同舟云学术

Standardization of allergen products: 3. Validation of candidate European Pharmacopoeia standard methods for quantification of major birch allergen Bet v 1

Published:2016-04-28 Issue:10 Volume:71 Page:1414-1424
ISSN:0105-4538
Container-title:Allergy
language:en
Short-container-title:Allergy

Author:

Kaul S.¹,Zimmer J.¹,Dehus O.¹,Costanzo A.²,Daas A.²,Buchheit K. H.²,Asturias J. A.³,Barber D.⁴,Carnés J.⁵,Chapman M.⁶,Dayan-Kenigsberg J.⁷,Döring S.¹,Führer F.¹,Hanschmann K. M.¹,Holzhauser T.¹,Ledesma A.⁴,Moingeon P.⁸,Nony E.⁸,Pini C.⁹,Plunkett G.¹⁰,Reese G.¹¹,Sandberg E.¹²,Sander I.¹³,Strecker D.¹,Valerio C.¹⁴,van Ree R.¹⁵,Vieths S.¹

Affiliation:

1. Paul-Ehrlich-Institut; Langen Germany

2. European Directorate for the Quality of Medicines & HealthCare (EDQM); Strasbourg France

3. BIAL Industrial Farmacéutica; Zamudio Spain

4. ALK-Abelló S/A; Madrid Spain

5. Laboratorios Leti S.L.; Tres Cantos Spain

6. Indoor Biotechnologies; Charlottesville VA USA

7. ANSM; Saint Denis Cedex France

8. Stallergenes Greer; Antony Cedex France

9. ISS CRIVIB; Roma Italy

10. ALK-Abelló Inc.; Round Rock TX USA

11. Allergopharma GmbH & Co. KG; Reinbek Germany

12. Danish Medicines Agency; Copenhagen S Denmark

13. Institute for Prevention and Occupational Medicine of the German Social Accident Insurance; Ruhr-Universität Bochum (IPA); Bochum Germany

14. Food and Drug Administration; Silver Spring MD USA

15. Academic Medical Centre; Amsterdam The Netherlands

Funder

EDQM

Publisher

Wiley

Subject

Immunology,Immunology and Allergy

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/all.12898/fullpdf

Reference31 articles.

1. European Pharmacopoeia Monograph on Allergen Products 1063

2. CHMP: Guideline on Allergen Products: Production and Quality Issues 2007

3. CHMP: Guideline on the clinical development of medicinal products for the treatment of allergic rhinoconjunctivitis

4. CHMP: Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases 2006

5. Standardization and Regulation of Allergen Products in the European Union;Zimmer;Curr Allergy Asthma Rep,2016

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