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About this book
As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products. But scientific challenges remain due to the complexity of both the manuf
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Yes, you can access Biosimilars by Shein-Chung Chow in PDF and/or ePUB format, as well as other popular books in Mathematics & Pharmacology. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- Cover
- Half Title
- Title Page
- Copyright Page
- Table of Contents
- Preface
- 1 Introduction
- 2 Bioequivalence Experience for Small-Molecule Drug Products
- 3 Regulatory Requirements for Assessing Follow-on Biologics
- 4 Criteria for Similarity
- 5 Statistical Methods for Assessing Average Biosimilarity
- 6 General App roach for Assessing Biosimilarity
- 7 Non-Inferiority versus Equivalence/Similarity
- 8 Statistical Test for Biosimilarity in Variability
- 9 Sample Size for Comparing Variabilities
- 10 Impact of Variability on Biosimilarity Limits for Assessing Follow-on Biologics
- 11 Drug Interch angeability
- 12 Issues on Immunogenicity Studies
- 13 CMC Requirements for Biological Products
- 14 Test for Compara bility in Manufacturing Process
- 15 Stability Analysis of Biosimilar Products
- 16 Assessing Biosimilarity Using Biomarker Data
- 17 Current Issues in Biosimilar Studies
- References