LEADER 03766oam 2200553I 450 001 9910153182903321 005 20240501163901.0 010 $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 205 $a1st ed. 210 1$aBoca Raton :$cTaylor & Francis,$d[2017] 210 4$dİ2017 215 $a1 online resource (269 pages) 225 1 $aChapman & Hall/CRC Biostatistics Series 300 $aA Chapman and Hall book--title page. 311 08$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. 330 $aBiosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies. 410 0$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