Coverart for item
The Resource Biosimilars : design and analysis of follow-on biologics, Shein-Chung Chow

Biosimilars : design and analysis of follow-on biologics, Shein-Chung Chow

Label
Biosimilars : design and analysis of follow-on biologics
Title
Biosimilars
Title remainder
design and analysis of follow-on biologics
Statement of responsibility
Shein-Chung Chow
Title variation
Design and analysis of follow-on biologics
Creator
Author
Subject
Language
eng
Summary
"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 $94 billion US dollars, accounting for about 15% of the pharmaceutical industry's gross revenue. Meanwhile, many biological products face losing their patents in the next decade"--
Member of
Assigning source
Provided by publisher
Cataloging source
N$T
http://library.link/vocab/creatorDate
1955-
http://library.link/vocab/creatorName
Chow, Shein-Chung
Dewey number
615.1/9
Illustrations
illustrations
Index
index present
LC call number
RS380
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
NLM call number
QV 241
Series statement
Chapman & Hall/CRC biostatistics series
http://library.link/vocab/subjectName
  • Pharmaceutical biotechnology
  • Pharmaceutical biotechnology industry
  • Drugs
  • Pharmaceutical policy
  • Biological products
  • Biosimilar Pharmaceuticals
  • Biostatistics
  • Drug Substitution
  • Technology, Pharmaceutical
  • MATHEMATICS
  • MEDICAL
  • MEDICAL
  • MEDICAL
  • MEDICAL
  • Biological products
  • Drugs
  • Pharmaceutical biotechnology
  • Pharmaceutical biotechnology industry
  • Pharmaceutical policy
Label
Biosimilars : design and analysis of follow-on biologics, Shein-Chung Chow
Instantiates
Publication
Copyright
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier.
Content category
text
Content type code
txt
Content type MARC source
rdacontent.
Contents
Introduction -- Bioequivalence experience for small-molecule drug products -- Regulatory requirements for assessing follow-on biologics -- Criteria for similarity -- Statistical methods for assessing average biosimilarity -- General approach for assessing biosimilarity -- Non-inferiority versus equivalence/similarity -- Statistical test for biosimilarity in variability -- Sample size for comparing variabilities -- Impact of variability on biosimilarity limits for assessing follow-on biologics -- Drug interchangeability -- Issues on immunogenicity studies -- CMC requirements for biological products -- Test for comparability in manufacturing process -- Stability analysis of biosimilar products -- Assessing biosimilarity using biomarker data -- Current issues in biosimilar studies
Control code
853506163
Extent
1 online resource (xix, 410 pages)
Form of item
online
Isbn
9781466579705
Media category
computer
Media MARC source
rdamedia.
Media type code
c
Other physical details
illustrations.
Specific material designation
remote
System control number
(OCoLC)853506163
Label
Biosimilars : design and analysis of follow-on biologics, Shein-Chung Chow
Publication
Copyright
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier.
Content category
text
Content type code
txt
Content type MARC source
rdacontent.
Contents
Introduction -- Bioequivalence experience for small-molecule drug products -- Regulatory requirements for assessing follow-on biologics -- Criteria for similarity -- Statistical methods for assessing average biosimilarity -- General approach for assessing biosimilarity -- Non-inferiority versus equivalence/similarity -- Statistical test for biosimilarity in variability -- Sample size for comparing variabilities -- Impact of variability on biosimilarity limits for assessing follow-on biologics -- Drug interchangeability -- Issues on immunogenicity studies -- CMC requirements for biological products -- Test for comparability in manufacturing process -- Stability analysis of biosimilar products -- Assessing biosimilarity using biomarker data -- Current issues in biosimilar studies
Control code
853506163
Extent
1 online resource (xix, 410 pages)
Form of item
online
Isbn
9781466579705
Media category
computer
Media MARC source
rdamedia.
Media type code
c
Other physical details
illustrations.
Specific material designation
remote
System control number
(OCoLC)853506163

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      38.939544 -92.328377
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