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Literature DB >> 22871707

In support of the European Union biosimilar framework.

Christian K Schneider, John J Borg, Falk Ehmann, Niklas Ekman, Esa Heinonen, Kowid Ho, Marcel H Hoefnagel, Roeland Martijn van der Plas, Sol Ruiz, Antonius J van der Stappen, Robin Thorpe, Klara Tiitso, Asterios S Tsiftsoglou, Camille Vleminckx, Guenter Waxenecker, Mats Welin, Martina Weise, Jean-Hugues Trouvin.

Abstract

Mesh：

Year: 2012 PMID： 22871707 DOI： 10.1038/nbt.2322

Source DB: PubMed Journal: Nat Biotechnol ISSN： 1087-0156 Impact factor: 54.908

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2 in total

1. Clinical comparability and European biosimilar regulations.

Authors: Huub Schellekens; Ellen Moors
Journal: Nat Biotechnol Date: 2010-01 Impact factor: 54.908

2. Toward biosimilar monoclonal antibodies.

Authors: Christian K Schneider; Ulrich Kalinke
Journal: Nat Biotechnol Date: 2008-09 Impact factor: 54.908

2 in total

13 in total

Review 1. Biosimilar: what it is not.

Authors: Fernando de Mora
Journal: Br J Clin Pharmacol Date: 2015-06-04 Impact factor: 4.335

2. Setting the stage for biosimilar monoclonal antibodies.

Authors: Christian K Schneider; Camille Vleminckx; Iordanis Gravanis; Falk Ehmann; Jean-Hugues Trouvin; Martina Weise; Steffen Thirstrup
Journal: Nat Biotechnol Date: 2012-12 Impact factor: 54.908

3. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327-01).

Authors: Donghua Yin; Kerry B Barker; Ruifeng Li; Xu Meng; Steven D Reich; Alejandro D Ricart; Dan Rudin; Carrie T Taylor; Charles M Zacharchuk; Arne G Hansson
Journal: Br J Clin Pharmacol Date: 2014-12 Impact factor: 4.335

Review 4. Addressing phenoconversion: the Achilles' heel of personalized medicine.

Authors: Rashmi R Shah; Robert L Smith
Journal: Br J Clin Pharmacol Date: 2015-02 Impact factor: 4.335

5. Moxifloxacin-induced QTc interval prolongations in healthy male Japanese and Caucasian volunteers: a direct comparison in a thorough QT study.

Authors: Joel Morganroth; Yaning Wang; Michael Thorn; Yuji Kumagai; Stuart Harris; Norman Stockbridge; Robert Kleiman; Rashmi Shah
Journal: Br J Clin Pharmacol Date: 2015-07-02 Impact factor: 4.335

Review 6. The emergence of biosimilar insulin preparations--a cause for concern?

Authors: David R Owens; Wolfgang Landgraf; Andrea Schmidt; Reinhard G Bretzel; Martin K Kuhlmann
Journal: Diabetes Technol Ther Date: 2012-10-09 Impact factor: 6.118

Review 7. State-of-the-art biosimilar erythropoietins in the management of renal anemia: lessons learned from Europe and implications for US nephrologists.

Authors: Adrian Covic; Ivo Abraham
Journal: Int Urol Nephrol Date: 2015-07-30 Impact factor: 2.370