03994nam 2200553 a 450 991081766160332120240313215026.01-118-63014-91-118-63021-1(CKB)2670000000359749(EBL)1188043(OCoLC)823930429(SSID)ssj0000885974(PQKBManifestationID)11499251(PQKBTitleCode)TC0000885974(PQKBWorkID)10816519(PQKB)11298419(MiAaPQ)EBC1188043(DLC) 2013001044(Au-PeEL)EBL1188043(CaPaEBR)ebr10704039(EXLCZ)99267000000035974920130109d2013 uy 0engur|||||||||||txtccrDrug-drug interactions for therapeutic biologics /edited by Honghui Zhou, Bernd Meibohm1st ed.Hoboken, N.J. John Wiley & Sonsc20131 online resource (379 p.)Description based upon print version of record.1-118-03216-0 Includes bibliographical references and index.Drug 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.Strategize, 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.<Drug interactionsDrug interactions.615.7/045Zhou Honghui1669465Meibohm Bernd1683368MiAaPQMiAaPQMiAaPQBOOK9910817661603321Drug-drug interactions for therapeutic biologics4054049UNINA