Literature DB >> 21880508

Intended use of reference products & WHO International Standards/Reference Reagents in the development of similar biological products (biosimilars).

Robin Thorpe1, Meenu Wadhwa.   

Abstract

Reference Products and WHO International Standards/Reference Reagents have roles to play in the development and characterization of similar biological products (SBPs). However, these roles are distinct and non-interchangeable. The uses of these materials and their limitations are considered in this paper.
Copyright © 2011. Published by Elsevier Ltd.

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Year:  2011        PMID： 21880508     DOI： 10.1016/j.biologicals.2011.06.005

Source DB:  PubMed          Journal:  Biologicals        ISSN： 1045-1056            Impact factor:   1.856


  6 in total

1.  Safety and tolerability of Lactobacillus reuteri DSM 17938 and effects on biomarkers in healthy adults: results from a randomized masked trial.

Authors:  Nisha Mangalat; Yuying Liu; Nicole Y Fatheree; Michael J Ferris; Melissa R Van Arsdall; Zhongxue Chen; Mohammad H Rahbar; Wallace A Gleason; Johana Norori; Dat Q Tran; J Marc Rhoads
Journal:  PLoS One       Date:  2012-09-06       Impact factor: 3.240

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

Authors:  Clive Metcalfe; Thomas Dougall; Chris Bird; Peter Rigsby; Marie-Emmanuelle Behr-Gross; Meenu Wadhwa; Participants Of The Study
Journal:  MAbs       Date:  2018-11-05       Impact factor: 5.857

3.  The First WHO International Standard for Adalimumab: Dual Role in Bioactivity and Therapeutic Drug Monitoring.

Authors:  Meenu Wadhwa; Chris Bird; Eleanor Atkinson; Isabelle Cludts; Peter Rigsby
Journal:  Front Immunol       Date:  2021-04-15       Impact factor: 7.561

Review 4.  Key concepts in biosimilar medicines: What physicians must know.

Authors:  Alper B Iskit
Journal:  North Clin Istanb       Date:  2022-02-10

5.  WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.

Authors:  Meenu Wadhwa; Hye-Na Kang; Robin Thorpe; Ivana Knezevic; P Aprea; M-C Bielsky; N Ekman; H-K Heim; J Joung; P Kurki; E Lacana; C Njue; E Nkansah; M Savkina; R Thorpe; T Yamaguchi; M Wadhwa; J Wang; M Weise; E Wolff-Holz
Journal:  Biologicals       Date:  2022-04-22       Impact factor: 1.760

6.  International standards for monoclonal antibodies to support pre- and post-marketing product consistency: Evaluation of a candidate international standard for the bioactivities of rituximab.

Authors:  Sandra Prior; Simon E Hufton; Bernard Fox; Thomas Dougall; Peter Rigsby; Adrian Bristow
Journal:  MAbs       Date:  2017-11-03       Impact factor: 5.857
  6 in total

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