Biosimilar clinical development : scientific considerations and new methodologies /: scientific considerations and new methodologies. ([2017])

• Record Type: Book
• Further Information: Note: Editors, Kerry B. Barker [and four others].
• Editors: Menon, Sandeep M; D'Agostino, Ralph B; Xu, Siyan; Bo Jin; Barker, Kerry B
• 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 / Jianfun (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.
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2017
• Copyright Date: 2017
• Extent: 1 online resource
• Subjects: 615.1/9; MEDICAL / Biostatistics; Biologicals; Drug development -- Methodology; MEDICAL / Pharmacology; Electronic books
• Languages: English
• ISBNs: 9781482231700; 1482231700; 9781315373263; 1315373262
• Related ISBNs: 9781482231694
• Notes: Note: Includes bibliographical references and index.; Note: Description based on online resource; title from PDF title page (EBSCO, viewed January 5, 2017).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.