Biosimilar Drug Product Development (Drugs And The Pharmaceutical Sciences)

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

• | Author: Laszlo Endrenyi|Paul Jules Declerck|Shein-Chung Chow, Laszlo Endrenyi
• | Publisher: CRC Press
• | Publication Date: Mar 07, 2017
• | Number of Pages: 496 pages
• | Language: English
• | Binding: Hardcover
• | ISBN-10: 1498718795
• | ISBN-13: 9781498718790