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Biosimilars : Design and Analysis of Follow-on Biologics.

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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 ch...

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Bibliographic Details
Online Access: Full Text (via ProQuest)
Main Author: Chow, Shein-Chung
Format: eBook
Language:English
Published: Hoboken : CRC Press, 2013.
Series:Chapman & Hall/CRC biostatistics series.
Subjects:
Biological products.
Drugs > Generic substitution.
Pharmaceutical biotechnology industry.
Pharmaceutical biotechnology.
Pharmaceutical policy.
Biologicals.
Table of Contents:
  • Front Cover; Contents; Preface; Chapter 1
  • Introduction; Chapter 2
  • Bioequivalence Experience for Small-Molecule Drug Products; Chapter 3
  • Regulatory Requirements for Assessing Follow-on Biologics; Chapter 4
  • Criteria for Similarity; Chapter 5
  • Statistical Methods for Assessing Average Biosimilarity; Chapter 6
  • General Approach for Assessing Biosimilarity; Chapter 7
  • Non-Inferiority versus Equivalence/Similarity; Chapter 8
  • Statistical Test for Biosimilarity in Variability; Chapter 9
  • Sample Size for Comparing Variabilities.
  • Chapter 10
  • Impact of Variability on Biosimilarity Limits for Assessing Follow-on BiologicsChapter 11
  • Drug Interchangeability; Chapter 12
  • Issues on Immunogenicity Studies; Chapter 13
  • CMC Requirements for Biological Products; Chapter 14
  • Test for Comparability in Manufacturing Process; Chapter 15
  • Stability Analysis of Biosimilar Products; Chapter 16
  • Assessing Biosimilarity Using Biomarker Data; Chapter 17
  • Current Issues in Biosimilar Studies; References; Back Cover.

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