Biosimilars Regulatory, Clinical, and Biopharmaceutical Development /
This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the qualit...
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| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | Englisch |
| Veröffentlicht: |
Cham :
Springer International Publishing,
2018.
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| Ausgabe: | 1st ed. 2018. |
| Schriftenreihe: | AAPS Advances in the Pharmaceutical Sciences Series,
34 |
| Schlagworte: | |
| ISBN: | 9783319996806 |
| ISSN: | 2210-7371 ; |
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Inhaltsangabe:
- Section I: Biosimilars, Regulatory landscape, health economics and Intellectual Property landscape
- Biosimilars 101 - An Introduction to Biosimilars
- Innovation, Patents and Biologics: The Road to Biosimilar Competition
- Factors influencing investment, business decisions and marketing of biosimilars
- The Changing US Reimbursement Landscape and Biosimilars
- Litigation-Related Issues Under The Biologics Price Competition and Innovation Act
- Section II: Target Product Profile, QbD, CMC, Biosimilar manufacture platform technologies
- Design and implementation of successful regulatory strategies in biosimilar development
- Health Canada's perspective on the clinical development of biosimilars and related scientific and regulatory challenges
- EU Perspective on Biosimilars
- Section III: Pharmaceutical development of Biosimilars; analytical comparability; higher order structure
- QbD in biopharmaceutical manufacturing and biosimilar development
- Drug Product Development and Manufacturing considerations for biosimilars
- Section IV: Biosimilars- clinical and non-clinical development; immunogenicity; Extrapolation and Interchangeability
- Principles of Analytical Biosimilarity Assessment
- Application of an Adaptive Analytical Characterization Strategy to Support Development and Approval of Biosimilars
- Higher Order Structure methods for similarity assessment
- Protein Conformational Array for Biologics Higher Order Structure Similarity Analysis
- Protein particulates and biosimilar development: analytical tools and therapeutic implications
- Biological activity assays for antibody therapeutics
- Statistical Considerations for Demonstration of Analytical Similarity
- Section V: Biosimilars- Global development and clinical experience
- Comparative clinical studies for biosimilar development
- Immunogenicity assessment of biosimilars: A multidisciplinary perspective
- Interchangeability of biosimilar therapeutics
- Extrapolation of Biosimilars
- Totality of evidence and the role of clinical studies in establishing biosimilarity
- Section VI: Biosimilars- Global Development and Clinical Experience
- Pharmacovigilance of Biosimilars - Global experience and perspective
- Development and Commercialization of Biosimilars in India - Current Regulatory and Clinical Experience.-Immunogenicty and adverse reactions to biocopy erythropoietins: The quality issues.