Contribution of animal studies to evaluate the similarity of biosimilars to reference products-Reference-Cited by-同舟云学术

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Contribution of animal studies to evaluate the similarity of biosimilars to reference products

Published:2015-04 Issue:4 Volume:20 Page:483-490
ISSN:1359-6446
Container-title:Drug Discovery Today
language:en
Short-container-title:Drug Discovery Today

Author:

van Meer Peter J.K.,Ebbers Hans C.,Kooijman Marlous,Gispen-de Wied Christine C.,Silva-Lima Beatriz,Moors Ellen H.M.,Schellekens Huub

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference63 articles.

1. Guideline on the Investigation of Bioequivalence;European Medicines Agency,2010

2. Shifting paradigms: biopharmaceuticals versus low molecular weight drugs;Crommelin;Int. J. Pharm.,2003

3. Protein aggregation: pathways, induction factors and analysis;Mahler;J. Pharm. Sci.,2009

4. Stability of protein pharmaceuticals: an update;Manning;Pharm. Res.,2010

5. Post-translational modifications of recombinant proteins: significance for biopharmaceuticals;Jenkins;Mol. Biotechnol.,2008

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4. End animal testing for biosimilar approval;Science;2022-07-08

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