The Resource Biosimilars : design and analysis of follow-on biologics, Shein-Chung Chow
Biosimilars : design and analysis of follow-on biologics, Shein-Chung Chow
Resource Information
The item Biosimilars : design and analysis of follow-on biologics, Shein-Chung Chow represents a specific, individual, material embodiment of a distinct intellectual or artistic creation found in University of Missouri Libraries.This item is available to borrow from 2 library branches.
Resource Information
The item Biosimilars : design and analysis of follow-on biologics, Shein-Chung Chow represents a specific, individual, material embodiment of a distinct intellectual or artistic creation found in University of Missouri Libraries.
This item is available to borrow from 2 library branches.
- 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"--
- Language
- eng
- Extent
- 1 online resource (xix, 410 pages)
- 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
- Isbn
- 9781466579705
- 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
- Subject
-
- Pharmaceutical biotechnology industry
- Biological products
- Pharmaceutical biotechnology
- Pharmaceutical biotechnology industry
- Drug Substitution
- Pharmaceutical biotechnology
- Biosimilar Pharmaceuticals
- Pharmaceutical policy
- MEDICAL -- Pharmacology
- MEDICAL -- Nursing | Pharmacology
- Technology, Pharmaceutical
- MEDICAL -- Pharmacy
- Drugs -- Generic substitution
- MATHEMATICS -- Probability & Statistics | General
- Pharmaceutical policy
- Biostatistics -- methods
- MEDICAL -- Drug Guides
- Biological products
- Drugs -- Generic substitution
- 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 $94 billion US dollars, accounting for about 15% of the pharmaceutical industry's gross revenue. Meanwhile, many biological products face losing their patents in the next decade"--
- Assigning source
- Provided by publisher
- Cataloging source
- N$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
- 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
- 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
Subject
- Biological products
- Biological products
- Biosimilar Pharmaceuticals
- Biostatistics -- methods
- Drug Substitution
- Drugs -- Generic substitution
- Drugs -- Generic substitution
- MATHEMATICS -- Probability & Statistics | General
- MEDICAL -- Drug Guides
- MEDICAL -- Nursing | Pharmacology
- MEDICAL -- Pharmacology
- MEDICAL -- Pharmacy
- Pharmaceutical biotechnology
- Pharmaceutical biotechnology
- Pharmaceutical biotechnology industry
- Pharmaceutical biotechnology industry
- Pharmaceutical policy
- Pharmaceutical policy
- Technology, Pharmaceutical
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.library.missouri.edu/portal/Biosimilars--design-and-analysis-of-follow-on/RM88zLTKb1s/" typeof="Book http://bibfra.me/vocab/lite/Item"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.library.missouri.edu/portal/Biosimilars--design-and-analysis-of-follow-on/RM88zLTKb1s/">Biosimilars : design and analysis of follow-on biologics, Shein-Chung Chow</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.library.missouri.edu/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.library.missouri.edu/">University of Missouri Libraries</a></span></span></span></span></div>
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<div class="citation" vocab="http://schema.org/"><i class="fa fa-external-link-square fa-fw"></i> Data from <span resource="http://link.library.missouri.edu/portal/Biosimilars--design-and-analysis-of-follow-on/RM88zLTKb1s/" typeof="Book http://bibfra.me/vocab/lite/Item"><span property="name http://bibfra.me/vocab/lite/label"><a href="http://link.library.missouri.edu/portal/Biosimilars--design-and-analysis-of-follow-on/RM88zLTKb1s/">Biosimilars : design and analysis of follow-on biologics, Shein-Chung Chow</a></span> - <span property="potentialAction" typeOf="OrganizeAction"><span property="agent" typeof="LibrarySystem http://library.link/vocab/LibrarySystem" resource="http://link.library.missouri.edu/"><span property="name http://bibfra.me/vocab/lite/label"><a property="url" href="http://link.library.missouri.edu/">University of Missouri Libraries</a></span></span></span></span></div>