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There are 8107 results for: content related to: Scientific considerations for assessing biosimilar products

  1. Biosimilar Drugs

    Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications, Second Edition

    Oliver Kayser, Heribert Warzecha, Pages: 285–335, 2012

    Published Online : 17 APR 2012, DOI: 10.1002/9783527632909.ch13

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    Biosimilars advancements: Moving on to the future

    Biotechnology Progress

    Volume 31, Issue 5, September/October 2015, Pages: 1139–1149, Lilian Rumi Tsuruta, Mariana Lopes dos Santos and Ana Maria Moro

    Version of Record online : 16 MAR 2015, DOI: 10.1002/btpr.2066

  3. Regulatory Strategies and Lessons in the Development of Biosimilars

    Standard Article

    Pharmaceutical Sciences Encyclopedia

    Umang S. Shah

    Published Online : 25 NOV 2013, DOI: 10.1002/9780470571224.pse511

  4. The State of the Art in the Development of Biosimilars

    Clinical Pharmacology & Therapeutics

    Volume 91, Issue 3, March 2012, Pages: 405–417, Mark McCamish and Gillian Woollett

    Version of Record online : 8 FEB 2012, DOI: 10.1038/clpt.2011.343

  5. Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation

    The Journal of Clinical Pharmacology

    Volume 55, Issue S3, March 2015, Pages: S123–S132, Bradley J. Scott, Agnes V. Klein and Jian Wang

    Version of Record online : 26 JUN 2014, DOI: 10.1002/jcph.339

  6. Biosimilars: how similar?

    Internal Medicine Journal

    Volume 44, Issue 3, March 2014, Pages: 218–223, V. Strand and B. Cronstein

    Version of Record online : 13 MAR 2014, DOI: 10.1111/imj.12292

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    Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications

    Diabetes, Obesity and Metabolism

    Volume 18, Issue 8, August 2016, Pages: 737–746, H. A. Dowlat, M. K. Kuhlmann, H. Khatami and F. J. Ampudia-Blasco

    Version of Record online : 20 MAY 2016, DOI: 10.1111/dom.12676

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    Biosimilar: what it is not

    British Journal of Clinical Pharmacology

    Volume 80, Issue 5, November 2015, Pages: 949–956, Fernando de Mora

    Version of Record online : 4 JUN 2015, DOI: 10.1111/bcp.12656

  9. Comments on the FDA draft guidance on biosimilar products

    Statistics in Medicine

    Volume 32, Issue 3, 10 February 2013, Pages: 364–369, Shein-Chung Chow, Laszlo Endrenyi and Peter A. Lachenbruch

    Version of Record online : 18 AUG 2012, DOI: 10.1002/sim.5572

  10. Application of the parallel line assay to assessment of biosimilar products based on binary endpoints

    Statistics in Medicine

    Volume 32, Issue 3, 10 February 2013, Pages: 449–461, Jr-Rung Lin, Shein-Chung Chow, Chih-Hsi Chang, Ya-Ching Lin and Jen-pei Liu

    Version of Record online : 22 AUG 2012, DOI: 10.1002/sim.5565

  11. On the interchangeability of biologic drug products

    Statistics in Medicine

    Volume 32, Issue 3, 10 February 2013, Pages: 434–441, Laszlo Endrenyi, Chiann Chang, Shein-Chung Chow and Laszlo Tothfalusi

    Version of Record online : 22 AUG 2012, DOI: 10.1002/sim.5569

  12. Biosimilar Development: Nonclinical and Clinical Strategies and Challenges with a Focus on the Role of PK/PD Assessments

    Standard Article

    Pharmaceutical Sciences Encyclopedia

    Susan Hurst and Donghua Yin

    Published Online : 30 DEC 2015, DOI: 10.1002/9780470571224.pse557

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    Biosimilar insulins: a European perspective

    Diabetes, Obesity and Metabolism

    Volume 17, Issue 5, May 2015, Pages: 445–451, J. H. DeVries, S. C. L. Gough, J. Kiljanski and L. Heinemann

    Version of Record online : 27 NOV 2014, DOI: 10.1111/dom.12410

  14. Biosimilars for Psoriasis: Worldwide Overview of Regulatory Guidelines, Uptake and Implications for Dermatology Clinical Practice

    British Journal of Dermatology

    Accepted manuscript online: 24 JUN 2017, A.D. Cohen, J.J. Wu, L. Puig, S. Chimenti, R. Vender, M. Rajagopalan, R. Romiti, C. de la Cruz, L. Skov, C. Zachariae, H.S. Young, P. Foley, J.M van der Walt, L. Naldi and A. Blauvelt

    DOI: 10.1111/bjd.15756

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    Biosimilar granulocyte–colony-stimulating factor for healthy donor stem cell mobilization: need we be afraid?

    Transfusion

    Volume 55, Issue 2, February 2015, Pages: 430–439, Halvard Bonig, Petra S. Becker, Arnd Schwebig and Matthew Turner

    Version of Record online : 26 JUN 2014, DOI: 10.1111/trf.12770

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    Biosimilars 101: considerations for U.S. oncologists in clinical practice

    Cancer Medicine

    Volume 3, Issue 4, August 2014, Pages: 889–899, Luis H. Camacho, Craig P. Frost, Esteban Abella, Phuong K. Morrow and Sadie Whittaker

    Version of Record online : 8 MAY 2014, DOI: 10.1002/cam4.258

  17. Statistical methods for assessing interchangeability of biosimilars

    Statistics in Medicine

    Volume 32, Issue 3, 10 February 2013, Pages: 442–448, Shein-Chung Chow, Lan-Yan Yang, Aijing Starr and Shih-Ting Chiu

    Version of Record online : 17 AUG 2012, DOI: 10.1002/sim.5566

    Corrected by:

    Correction: Correction

    Vol. 32, Issue 18, 3234, Version of Record online: 24 JAN 2013

  18. Analytical strategies for assessing comparability of biosimilars

    Journal of Chemical Technology and Biotechnology

    Volume 86, Issue 7, July 2011, Pages: 915–922, Robert J. Falconer, Dianne Jackson-Matthews and Stephen M. Mahler

    Version of Record online : 26 APR 2011, DOI: 10.1002/jctb.2629

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    Biosimilars in psoriasis: What can we expect?

    JDDG: Journal der Deutschen Dermatologischen Gesellschaft

    Volume 12, Issue 4, April 2014, Pages: 306–312, Marc Alexander Radtke and Matthias Augustin

    Version of Record online : 2 APR 2014, DOI: 10.1111/ddg.12294

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    Biosimilar agents in oncology/haematology: from approval to practice

    European Journal of Haematology

    Volume 86, Issue 4, April 2011, Pages: 277–288, Dietger Niederwieser and Stephan Schmitz

    Version of Record online : 25 JAN 2011, DOI: 10.1111/j.1600-0609.2010.01566.x