The first World Health Organization International Standard for infliximab products: A step towards maintaining harmonized biological activity-Reference-Cited by-同舟云学术

The first World Health Organization International Standard for infliximab products: A step towards maintaining harmonized biological activity

Published:2018-11-05 Issue:1 Volume:11 Page:13-25
ISSN:1942-0862
Container-title:mAbs
language:en
Short-container-title:mAbs

Author:

Metcalfe Clive¹^ORCID,Dougall Thomas²^ORCID,Bird Chris¹,Rigsby Peter²,Behr-Gross Marie-Emmanuelle³,Wadhwa Meenu¹,study participants of the

Affiliation:

1. Division of Biotherapeutics, National Institute for Biological Standards and Control (NIBSC), South Mimms, Potters Bar, Hertfordshire, UK

2. Division of Technology Development and Infrastructure, National Institute for Biological Standards and Control, South Mimms, UK

3. Department of Biological Standardisation, OMCL Network & HealthCare (DBO), European Directorate for the Quality of Medicines and HealthCare (EDQM), Strasbourg, France

Funder

UK Department of Health

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

Link

https://www.tandfonline.com/doi/pdf/10.1080/19420862.2018.1532766

Reference42 articles.

1. WHO Expert Committee on Biological Standarisation. Sixty sixth Report. Report of a WHO informal consulation on international standards for biotherapeutic products; 2016. WHO Technical Report Series 999, p. 13–15.

2. WHO Expert Committee on Biological Standardization. Sixtieth report. Guidelines on evaluation of similar biotherapeutic products (SBPs). WHO Technical Report Series, No.977, Annex 2; 2013. http://www.who.int/biologicals/expert_committee/TR.

3. Intended use of Reference Products & WHO International Standards/Reference Reagents in the development of Similar Biological Products (Biosimilars)

4. WHO Expert Committee on Biological Standarisation. Fifty fifth Report. Recommendations for the preparation, characterization and establishmentof international and other biological reference standards. WHO Technical Report Series 932; 2006, p. 73–130.

5. Interaction databases on the same page

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