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Biosimilars : Design and Analysis of Follow-on Biologics.
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...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Hoboken :
CRC Press,
2013.
|
| Colección: | Chapman & Hall/CRC biostatistics series.
|
| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 003 | OCoLC | ||
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| 035 | |a (OCoLC)854975436 | ||
| 050 | 4 | |a RS380 .C45 2014 | |
| 082 | 0 | 4 | |a 610.28 |a 615.1/9 |a 615.19 |
| 049 | |a UAMI | ||
| 100 | 1 | |a Chow, Shein-Chung. | |
| 245 | 1 | 0 | |a Biosimilars : |b Design and Analysis of Follow-on Biologics. |
| 260 | |a Hoboken : |b CRC Press, |c 2013. | ||
| 300 | |a 1 online resource (433 pages). | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 490 | 1 | |a Chapman & Hall/CRC Biostatistics Series | |
| 505 | 0 | |a 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. | |
| 505 | 8 | |a 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. | |
| 520 | |a 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 manufacturing process and the structures of biosimilar products. Written by a top biostatistics researcher, Biosimilars: Design and Analysis of Follow-on Biologics is the first book entirely devoted to the statistical design and analysis of biosimilarity. | ||
| 588 | 0 | |a Print version record. | |
| 590 | |a ProQuest Ebook Central |b Ebook Central Academic Complete | ||
| 650 | 0 | |a Biological products. | |
| 650 | 0 | |a Drugs |x Generic substitution. | |
| 650 | 0 | |a Pharmaceutical biotechnology industry. | |
| 650 | 0 | |a Pharmaceutical biotechnology. | |
| 650 | 0 | |a Pharmaceutical policy. | |
| 650 | 0 | |a Biologicals. | |
| 650 | 2 | |a Biological Factors | |
| 650 | 2 | |a Biological Products | |
| 650 | 6 | |a Produits biologiques. | |
| 650 | 6 | |a Médicaments |x Dénomination commune. | |
| 650 | 6 | |a Biotechnologie pharmaceutique |x Industrie. | |
| 650 | 6 | |a Biotechnologie pharmaceutique. | |
| 650 | 6 | |a Médicaments |x Politique gouvernementale. | |
| 650 | 6 | |a Médicaments biologiques. | |
| 650 | 7 | |a Biologicals |2 fast | |
| 650 | 7 | |a Biological products |2 fast | |
| 650 | 7 | |a Drugs |x Generic substitution |2 fast | |
| 650 | 7 | |a Pharmaceutical biotechnology |2 fast | |
| 650 | 7 | |a Pharmaceutical biotechnology industry |2 fast | |
| 650 | 7 | |a Pharmaceutical policy |2 fast | |
| 758 | |i has work: |a Biosimilars (Text) |1 https://id.oclc.org/worldcat/entity/E39PCGjFPj6BYxHvFpHpMxmR4y |4 https://id.oclc.org/worldcat/ontology/hasWork | ||
| 776 | 0 | 8 | |i Print version: |a Chow, Shein-Chung. |t Biosimilars : Design and Analysis of Follow-on Biologics. |d Hoboken : CRC Press, ©2013 |z 9781466579699 |
| 830 | 0 | |a Chapman & Hall/CRC biostatistics series. | |
| 856 | 4 | 0 | |u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=1316405 |z Texto completo |
| 938 | |a ProQuest Ebook Central |b EBLB |n EBL1316405 | ||
| 994 | |a 92 |b IZTAP | ||