03237oam 2200529I 450 991015318290332120230810001419.01-315-37326-21-315-35590-61-4822-3170-010.1201/9781315373263 (CKB)3710000000960834(MiAaPQ)EBC4748363(OCoLC)966398076(EXLCZ)99371000000096083420180331h20172017 uy 0engurcnu||||||||rdacontentrdamediardacarrierBiosimilar 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 UniBoca Raton :Taylor & Francis,[2017]©20171 online resource (269 pages)Chapman & Hall/CRC Biostatistics SeriesA Chapman and Hall book--title page.1-4822-3169-7 Includes bibliographical references at the end of each chapters and index.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.Chapman & Hall/CRC biostatistics series.BiologicalsDrug developmentMethodologyBiologicals.Drug developmentMethodology.615.1/9Barker Kerry B.Menon Sandeep M.D'Agostino Ralph B.Xu SiyanJin BoFlBoTFGFlBoTFGBOOK9910153182903321Biosimilar clinical development2091161UNINA