Biosimilar Drug Product Development
Cover -- Half Title -- Title Page -- Copyright Page -- Contents -- Preface -- Contributors -- Chapter 1 Introduction: Scientific Factors in Biosimilar Product Development -- Chapter 2 Analytical Characterization: Structural Assessment of Biosimilarity -- Chapter 3 Analytical Similarity Assessment -- Chapter 4 Characterization of Biosimilar Biologics: The Link between Structure and Functions -- Chapter 5 Manufacturing and Process Control Issues: Quality Development of Biosimilar Medicinal Produc…
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- Full title :Biosimilar Drug Product Development
Summary
Cover -- Half Title -- Title Page -- Copyright Page -- Contents -- Preface -- Contributors -- Chapter 1 Introduction: Scientific Factors in Biosimilar Product Development -- Chapter 2 Analytical Characterization: Structural Assessment of Biosimilarity -- Chapter 3 Analytical Similarity Assessment -- Chapter 4 Characterization of Biosimilar Biologics: The Link between Structure and Functions -- Chapter 5 Manufacturing and Process Control Issues: Quality Development of Biosimilar Medicinal Products -- Chapter 6 Nonclinical Studies for Biosimilars -- Chapter 7 The Clinical Development of Biosimilar Drugs -- Chapter 8 Statistical Methods for Assessing Biosimilarity -- Chapter 9 Extrapolation of Indications for Biosimilars: Opportunity for Developers and Challenges for Regulators -- Chapter 10 Interchangeability, Switchability, and Substitution of Biosimilar Products -- Chapter 11 Design and Analysis of Studies for Assessing Interchangeability -- Chapter 12 The Role of the Immunogenicity Evaluation for Biosimilars -- Chapter 13 Pharmacovigilance of Biosimilars -- Chapter 14 Patent Exclusivities Affecting Biosimilars in the United States, Canada, and Europe -- Chapter 15 Biosimilars in the EU: Regulatory Guidelines -- Chapter 16 Biosimilars and Biologics: The Prospects for Competition -- Chapter 17 Plant-Based Production of Biosimilar Drug Products -- Index
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- Publication Date:2017
Publication Statements
- Publisher(s):CRC Press
- Place of Publication:Boca Raton
- Language:eng
- Publication Date:2017
The Physical Object
- Description:1 Online-Ressource (496 Seiten)
Edition Identifiers
- ISBN:9781498718806, 1498718809, 9781498718790, 1498718795
- oclc:on1020858782
- LC Classification:RM301.25
- Dewey Decimal:615.1/9
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