The Resource Biosimilar clinical development : scientific considerations and new methodologies, edited by Kerry B. Barker, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Ralph B. D'Agostino, Sr., Boston University, Massachusetts, USA, Siyan Xu, Novartis, Cambridge, Massachusetts, USA, Bo Jin, Pfizer, Cambridge, Massachusetts, USA

Biosimilar clinical development : scientific considerations and new methodologies, edited by Kerry B. Barker, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Ralph B. D'Agostino, Sr., Boston University, Massachusetts, USA, Siyan Xu, Novartis, Cambridge, Massachusetts, USA, Bo Jin, Pfizer, Cambridge, Massachusetts, USA

Label
Biosimilar clinical development : scientific considerations and new methodologies
Title
Biosimilar clinical development
Title remainder
scientific considerations and new methodologies
Statement of responsibility
edited by Kerry B. Barker, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Ralph B. D'Agostino, Sr., Boston University, Massachusetts, USA, Siyan Xu, Novartis, Cambridge, Massachusetts, USA, Bo Jin, Pfizer, Cambridge, Massachusetts, USA
Contributor
Editor
Subject
Language
eng
Summary
Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies
Member of
Cataloging source
CRCPR
Dewey number
615.19
Illustrations
  • illustrations
  • portraits
  • charts
Index
index present
LC call number
RS162
LC item number
.B5612 2017
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Series statement
Chapman & Hall/CRC biostatistics series
Label
Biosimilar clinical development : scientific considerations and new methodologies, edited by Kerry B. Barker, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Ralph B. D'Agostino, Sr., Boston University, Massachusetts, USA, Siyan Xu, Novartis, Cambridge, Massachusetts, USA, Bo Jin, Pfizer, Cambridge, Massachusetts, USA
Publication
Copyright
Note
"A Chapman & Hall book."
Bibliography note
Includes bibliographical references and index
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
1. Biosimilars for drug development : the time is now! / Bo Jin, Sandeep M. Menon, Kerry B. Barker, and Ralph B. D'Agostino -- 2. From isolation to integration : a systems biology approach for the discovery of therapeutic targets and biomarkers / Attila Seyhan and Claudio Carini -- 3. Immunogenicity of biological products : current perspectives and future implications / Candida Fratazzi, Attila Seyhan, and Claudio Carini -- 4. Interchangeability between biosimilar and innovator drug products / Bo Jin, Sandeep M. Menon, Kerry B. Barker, and Steven Ye Hua -- 5. Bridging a new biological product with its reference product /Jianjun (David) Li and Jin Xu -- 6. Accounting for covariate effect to show noninferiority in biosimilars / Siyan Xu, Kerry B. Barker, Sandeep M. Menon, and Ralph B. D'Agostino -- 7. Novel method in inference of equivalence in biosimilars / Siyan Xu, Steven Ye Hua, Ronald Menton, Kerry B. Barker, Sandeep M. Menon, and Ralph B. D'Agostino -- 8. Multiplicity adjustments in testing for bioequivalence / Steven Ye Hua, Siyan Xu, and Ralph B. D'Agostino -- 9. Bayesian methods to assess bioequivalence and biosimilarity with case studies / Steven Ye Hua, Siyan Xu, Kerry B. Barker, Shan Mei Liao, and Shujie Li -- 10. Average inferiority measure and standardized margins to address the issues in biosimilar trials / Gang Li and Weichung Joe Shih -- 11. Bayesian methods for design and analysis of noninferiority trials / Mani Lakshminarayanan and Fanni Natanegara
Control code
ocn966398076
Dimensions
unknown
Extent
1 online resource
Form of item
online
Isbn
9781482231700
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
text file, PDF
http://library.link/vocab/recordID
.b37382822
Specific material designation
remote
System control number
  • (OCoLC)966398076
  • pebc1315355906

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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