Biosimilars : design and analysis of follow-on biologics
by
Chow, Shein-Chung, 1955- author.
Title
:
Biosimilars : design and analysis of follow-on biologics
Author
:
Chow, Shein-Chung, 1955- author.
ISBN
:
9781466579705
Physical Description
:
1 online resource : text file, PDF
Series
:
Chapman & Hall/CRC biostatistics series ; 60
Series Title
:
Chapman & Hall/CRC biostatistics series ; 60
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.
Abstract
:
"This is the first book entirely devoted to the design and analysis for assessment of biosimilarity and drug interchangeability of biosimilars, and test for comparability in manufacturing processes of biologic products. It covers all of the statistical issues that may occur in biosimilar studies under various study designs at various stages of research and development of biologic products"-- Provided by publisher.
"Biologic drug products are therapeutic moieties that are manufactured using a living system or organism. These are important life-saving drug products for patients with unmet medical needs. They also comprise a growing segment in the pharmaceutical industry. In 2007, for instance, worldwide sales of biological products reached $94 billion US dollars, accounting for about 15% of the pharmaceutical industry's gross revenue. Meanwhile, many biological products face losing their patents in the next decade"-- Provided by publisher.
Subject Term
:
Pharmaceutical biotechnology.
Pharmaceutical biotechnology industry.
Drugs -- Generic substitution.
Pharmaceutical policy.
Biological products.
Electronic Access
:
| Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
|---|
| Online Library | E-Book | 287275-1001 | ONLINE | | Elektronik Kütüphane |