LEADER 03237oam 2200529I 450 001 9910153182903321 005 20230810001419.0 010 $a1-315-37326-2 010 $a1-315-35590-6 010 $a1-4822-3170-0 024 7 $a10.1201/9781315373263 035 $a(CKB)3710000000960834 035 $a(MiAaPQ)EBC4748363 035 $a(OCoLC)966398076 035 $a(EXLCZ)993710000000960834 100 $a20180331h20172017 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $2rdacontent 182 $2rdamedia 183 $2rdacarrier 200 00$aBiosimilar clinical development $escientific considerations and new methodologies /$fedited by Kerry B. Barker, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Ralph B. D'Agostino, Sr., Boston Uni 210 1$aBoca Raton :$cTaylor & Francis,$d[2017] 210 4$dİ2017 215 $a1 online resource (269 pages) 225 1 $aChapman & Hall/CRC Biostatistics Series 300 $aA Chapman and Hall book--title page. 311 $a1-4822-3169-7 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $a1. Biosimilars for drug development : the time is now! / Bo Jin, Sandeep M. Menon, Kerry B. Barker, and Ralph B. D'Agostino -- 2. From isolation to integration : a systems biology approach for the discovery of therapeutic targets and biomarkers / Attila Seyhan and Claudio Carini -- 3. Immunogenicity of biological products : current perspectives and future implications / Candida Fratazzi, Attila Seyhan, and Claudio Carini -- 4. Interchangeability between biosimilar and innovator drug products / Bo Jin, Sandeep M. Menon, Kerry B. Barker, and Steven Ye Hua -- 5. Bridging a new biological product with its reference product /Jianjun (David) Li and Jin Xu -- 6. Accounting for covariate effect to show noninferiority in biosimilars / Siyan Xu, Kerry B. Barker, Sandeep M. Menon, and Ralph B. D'Agostino -- 7. Novel method in inference of equivalence in biosimilars / Siyan Xu, Steven Ye Hua, Ronald Menton, Kerry B. Barker, Sandeep M. Menon, and Ralph B. D'Agostino -- 8. Multiplicity adjustments in testing for bioequivalence / Steven Ye Hua, Siyan Xu, and Ralph B. D'Agostino -- 9. Bayesian methods to assess bioequivalence and biosimilarity with case studies / Steven Ye Hua, Siyan Xu, Kerry B. Barker, Shan Mei Liao, and Shujie Li -- 10. Average inferiority measure and standardized margins to address the issues in biosimilar trials / Gang Li and Weichung Joe Shih -- 11. Bayesian methods for design and analysis of noninferiority trials / Mani Lakshminarayanan and Fanni Natanegara. 410 0$aChapman & Hall/CRC biostatistics series. 606 $aBiologicals 606 $aDrug development$xMethodology 615 0$aBiologicals. 615 0$aDrug development$xMethodology. 676 $a615.1/9 702 $aBarker$b Kerry B. 702 $aMenon$b Sandeep M. 702 $aD'Agostino$b Ralph B. 702 $aXu$b Siyan 702 $aJin$b Bo 801 0$bFlBoTFG 801 1$bFlBoTFG 906 $aBOOK 912 $a9910153182903321 996 $aBiosimilar clinical development$92091161 997 $aUNINA