Biosimilars : design and analysis of follow-on biologics /: design and analysis of follow-on biologics. ([2014])

• Record Type: Book
• Other Titles: Design and analysis of follow-on biologics
• Further Information: Note: Shein-Chung Chow.
• Authors: Chow, Shein-Chung, 1955-
• Contents: 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 approach 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 interchangeability -- 12. Issues on immunogenicity studies -- 13. CMC requirements for biological products -- 14. Test for comparability in manufacturing process -- 15. Stability analysis of biosimilar products -- 16. Assessing biosimilarity using biomarker data -- 17. Current issues in biosimilar studies.
• Publisher Details: Boca Raton, FL : CRC Press/Taylor & Francis Group
• Publication Date: 2014
• Copyright Date: 2014
• Extent: 1 online resource (xix, 410 pages), illustrations
• Subjects: 615.1/9; Pharmaceutical biotechnology; Pharmaceutical biotechnology industry; Drugs -- Generic substitution; Pharmaceutical policy; Biological products; MATHEMATICS -- Probability & Statistics -- General; MEDICAL -- Pharmacology; MEDICAL -- Drug Guides; MEDICAL -- Nursing -- Pharmacology; MEDICAL -- Pharmacy; Biological products; Drugs -- Generic substitution; Pharmaceutical biotechnology; Pharmaceutical biotechnology industry; Pharmaceutical policy; Biosimilar Pharmaceuticals; Biostatistics -- methods; Drug Substitution; Technology, Pharmaceutical; Electronic books; Electronic books
• Languages: English
• ISBNs: 9781466579705; 1466579706
• Related ISBNs: 9781466579699; 1466579692
• Notes: Note: Includes bibliographical references and index.; Note: Online resource; title from resource home page (ebrary, viewed November 10, 2015).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.