Literature DB >> 26428936

Analytical and Biological Characterization of a Noninnovator Insulin Glargine and the Originator Drug Product.

Abraham Escobedo-Moratilla1, Francisco Kuri-Breña Romero de Terreros2, José Pérez-Urizar3, Ana Paulina Barba de la Rosa4.   

Abstract

Entities:  

Keywords:  analytical characterization; biosimilar; biotechnology; insulin analogues; mass spectrometry; protein structure

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Year:  2015        PMID： 26428936      PMCID： PMC4773961          DOI： 10.1177/1932296815606914

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN： 1932-2968


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  3 in total

1.  Acceptable changes in quality attributes of glycosylated biopharmaceuticals.

Authors:  Martin Schiestl; Thomas Stangler; Claudia Torella; Tadej Cepeljnik; Hansjörg Toll; Roger Grau
Journal:  Nat Biotechnol       Date:  2011-04       Impact factor: 54.908

Review 2.  Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations.

Authors:  George Dranitsaris; Eitan Amir; Kristine Dorward
Journal:  Drugs       Date:  2011-08-20       Impact factor: 9.546

Review 3.  An Overview of Current Regulatory Requirements for Approval of Biosimilar Insulins.

Authors:  Lutz Heinemann; Hootan Khatami; Ross McKinnon; Philip Home
Journal:  Diabetes Technol Ther       Date:  2015-03-19       Impact factor: 6.118
  3 in total

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