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Biosimilars

Overview of attention for book
Cover of 'Biosimilars'

Table of Contents

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    Book Overview
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    Chapter 1 Biosimilars 101: An Introduction to Biosimilars
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    Chapter 2 Innovation, Patents and Biologics: The Road to Biosimilar Competition: Factors Influencing Investment, Business Decisions and Marketing of Biosimilars
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    Chapter 3 The Changing US Reimbursement Landscape and Biosimilars
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    Chapter 4 Litigation-Related Issues Under the Biologics Price Competition and Innovation Act
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    Chapter 5 Design and Implementation of Successful Regulatory Strategies in Biosimilar Development
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    Chapter 6 Clinical Information Requirements for Biosimilar Biologic Drug Approvals in Canada
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    Chapter 7 EU Perspective on Biosimilars
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    Chapter 8 Biosimilars Drug Substance Development and Manufacturing: Effective CMC Strategy
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    Chapter 9 QbD in Biopharmaceutical Manufacturing and Biosimilar Development
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    Chapter 10 Drug Product Considerations for Biosimilars
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    Chapter 11 Principles of Analytical Similarity Assessment
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    Chapter 12 Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval of Biosimilars
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    Chapter 13 Higher Order Structure Methods for Similarity Assessment
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    Chapter 14 Protein Conformational Array Technology for Biosimilar Higher Order Structure Analysis
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    Chapter 15 Protein Particulates and Biosimilar Development: Analytical Tools and Therapeutic Implications
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    Chapter 16 Biological Activity Assays for Antibody Therapeutics
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    Chapter 17 Statistical Considerations for Demonstration of Analytical Similarity
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    Chapter 18 Comparative Clinical Studies for Biosimilars as Part of a Stepwise Approach
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    Chapter 19 Immunogenicity Assessment of Biosimilars: A Multidisciplinary Perspective
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    Chapter 20 Interchangeability Study Design and Analysis
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    Chapter 21 Extrapolation
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    Chapter 22 Totality of Evidence and the Role of Clinical Studies in Establishing Biosimilarity
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    Chapter 23 Pharmacovigilance of Biosimilars: Global Experience and Perspective
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    Chapter 24 Development and Commercialization of Biosimilars in India: Current Regulatory and Clinical Experience
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    Chapter 25 Immunogenicity and Adverse Reactions to Biosimilar Erythropoietin Products in Thailand: The Significance of Science and Quality Driven Process for Approval
Attention for Chapter 18: Comparative Clinical Studies for Biosimilars as Part of a Stepwise Approach
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Citations

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Chapter title
Comparative Clinical Studies for Biosimilars as Part of a Stepwise Approach
Chapter number 18
Book title
Biosimilars
Published by
Springer, Cham, December 2018
DOI 10.1007/978-3-319-99680-6_18
Book ISBNs
978-3-31-999679-0, 978-3-31-999680-6
Authors

Thomas E. Gwise

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 3 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 3 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 2 67%
Student > Master 1 33%
Readers by discipline Count As %
Medicine and Dentistry 3 100%

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