Biosimilar Development: Nonclinical and Clinical Strategies and Challenges with a Focus on the Role of PK/PD Assessments-Reference-Cited by-同舟云学术

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

Published:2015-12-30 Issue: Volume: Page:1-16
ISSN:
Container-title:Pharmaceutical Sciences Encyclopedia
language:
Short-container-title:

Author:

Hurst Susan¹,Yin Donghua²

Affiliation:

1. Pfizer Worldwide Research and Development; Groton CT USA

2. Pfizer Worldwide Research and Development; San Diego CA USA

Publisher

John Wiley & Sons, Inc.

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/9780470571224.pse557/fullpdf

Reference49 articles.

1. Large-scale mammalian cell culture;Hu;Curr Opin Biotechnol,1997

2. Cell culture processes for monoclonal antibody production;Li;MAbs,2010

3. EMA 2015 Similar biological medicinal products http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf

4. EMA 2014 Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500167838.pdf

5. FDA 2015 Quality considerations in demonstrating biosimilarity to a reference protein product: Guidance for industry http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf

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