LEADER 04062nam 2200577 a 450 001 9910817661603321 005 20240313215026.0 010 $a1-118-63014-9 010 $a1-118-63021-1 035 $a(CKB)2670000000359749 035 $a(EBL)1188043 035 $a(OCoLC)823930429 035 $a(SSID)ssj0000885974 035 $a(PQKBManifestationID)11499251 035 $a(PQKBTitleCode)TC0000885974 035 $a(PQKBWorkID)10816519 035 $a(PQKB)11298419 035 $a(MiAaPQ)EBC1188043 035 $a(DLC) 2013001044 035 $a(Au-PeEL)EBL1188043 035 $a(CaPaEBR)ebr10704039 035 $a(OCoLC)823380571 035 $a(FINmELB)ELB178659 035 $a(EXLCZ)992670000000359749 100 $a20130109d2013 uy 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aDrug-drug interactions for therapeutic biologics /$fedited by Honghui Zhou, Bernd Meibohm 205 $a1st ed. 210 $aHoboken, N.J. $cJohn Wiley & Sons$dc2013 215 $a1 online resource (379 p.) 300 $aDescription based upon print version of record. 311 $a1-118-03216-0 320 $aIncludes bibliographical references and index. 327 $aDrug interactions for therapeutic proteins : a journey just beginning / Honghui Zhou, Bernd Meibohm -- Pharmacokinetic and pharmacodynamic-based drug interactions for therapeutic proteins / Dan Lu ... [et al.] -- Drug interaction assessment strategies : small molecules versus therapeutic proteins / Shannon Dallas ... [et al.] -- Model-independent and modeling-based methods to assess drug-drug interactions for therapeutic proteins / Di Wu, Jeffrey Barrett -- Utility of in vitro methods in drug-drug interaction assessment and prediction for therapeutic biologics / Theresa Nguyen, Narendra Kishnani, Raymond Evers -- Use of animal models for projection of clinical drug-drug interactions for therapeutic proteins / Eugenia Kraynov, Martin E. Dowty -- The "cocktail" approach and its utility in drug-drug interaction assessments for therapeutic proteins / Alexander Jetter, Uwe Fuhr -- Logistic considerations in study design for biologic drug-drug interaction assessments / Min Zhu and Yu-Nien (Tom) Sun -- Statistical considerations in assessing drug-drug interactions for therapeutic proteins / Chuanpu Hu and Honghui Zhou -- FDA perspectives on therapeutic protein drug-drug interaction assessments / Hong Zhao ... [et al.] -- Disease-drug-drug interaction assessments for tocilizumab : a monoclonal antibody against interleukin-6 receptor to treat patients with rheumatoid arthritis / Xuapang Zhang and Barbara J. Brennan -- -- Drug-drug interactions for etamercept : a fusion protein / Joan Korth-Bradley -- Drug interactions of cytokines and anti-cytokine therapeutic proteins / J. Greg Slatter L.C. Wienkers and Leslie J. Dickmann -- Drug interactions for growth factors and hormones / Yow-Ming Wang, Tarundeep Kakkar -- Drug-drug interactions for nucleic acid-based derivatires / Jan Wang and Hong Zhao. 330 $aStrategize, plan, and execute comprehensive drug-drug interaction assessments for therapeutic biologics Offering both theory and practical guidance, this book fully explores drug-drug interaction assessments for therapeutic biologics during the drug development process. It draws together and analyzes all the latest findings and practices in order to present our current understanding of the topic and point the way to new research. Case studies and examples, coupled with expert advice, enable readers to better understand the complex mechanisms of biologic drug-drug interactions.< 606 $aDrug interactions 615 0$aDrug interactions. 676 $a615.7/045 701 $aZhou$b Honghui$01669465 701 $aMeibohm$b Bernd$01683368 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910817661603321 996 $aDrug-drug interactions for therapeutic biologics$94054049 997 $aUNINA