Zhou / Meibohm Drug-Drug Interactions for Therapeutic Biologics

1. Auflage 2013
ISBN: 978-1-118-63014-3
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 378 Seiten, E-Book

Strategize, plan, and execute comprehensive drug-druginteraction assessments for therapeutic biologics
Offering both theory and practical guidance, this book fullyexplores drug-drug interaction assessments for therapeuticbiologics during the drug development process. It draws togetherand analyzes all the latest findings and practices in order topresent our current understanding of the topic and point the way tonew research. Case studies and examples, coupled with expertadvice, enable readers to better understand the complex mechanismsof biologic drug-drug interactions.
Drug-Drug Interactions for Therapeutic Biologics featurescontributions from leading international experts in all areas oftherapeutic biologics drug development and drug-drug interactions.The authors' contributions reflect a thorough review and analysisof the literature as well as their own firsthand laboratoryexperience. Coverage includes such essential topics as:
* Drug-drug interaction risks in combination with small moleculesand other biologics
* Pharmacokinetic and pharmacodynamic drug-drug interactions
* In vitro methods for drug-drug interaction assessment andprediction
* Risk-based strategies for evaluating biologic drug-druginteractions
* Strategies to minimize drug-drug interaction risk and mitigatetoxic interactions
* Key regulations governing drug-drug interaction assessments fortherapeutic biologics.
Drug-Drug Interactions for Therapeutic Biologics isrecommended for pharmaceutical and biotechnology scientists,clinical pharmacologists, medicinal chemists, and toxicologists. Byenabling these readers to understand how therapeutic biologics mayinteract with other drugs, the book will help them develop safer,more effective therapeutic biologics.

Autoren/Hrsg.

Zhou, Honghui

Meibohm, Bernd

Inhaltsverzeichnis

PREFACE ix
ABOUT THE EDITORS xi
CONTRIBUTORS xiii
1. DRUG INTERACTIONS FOR THERAPEUTIC PROTEINS: A JOURNEY JUSTBEGINNING 1
Honghui Zhou and Bernd Meibohm
2. PHARMACOKINETIC AND PHARMACODYNAMIC-BASED DRUGINTERACTIONS FOR THERAPEUTIC PROTEINS 5
Dan Lu, Sandhya Girish, Frank-Peter Theil, and AmitaJoshi
3. DRUG INTERACTION ASSESSMENT STRATEGIES: SMALL MOLECULESVERSUS THERAPEUTIC PROTEINS 39
Shannon Dallas, Carlo Sensenhauser, Souvik Chattopadhyay, andJose Silva
4. MODEL-INDEPENDENT AND MODEL-BASED METHODS TO ASSESSDRUG-DRUG INTERACTIONS FOR THERAPEUTIC PROTEINS 63
Di Wu and Jeffrey S. Barrett
5. UTILITY OF IN VITRO METHODS IN DRUG-DRUG INTERACTIONASSESSMENT AND PREDICTION FOR THERAPEUTIC BIOLOGICS 73
Theresa Nguyen, Narendra Kishnani, and Raymond Evers
6. USE OF ANIMAL MODELS FOR PROJECTION OF CLINICALDRUG-DRUG INTERACTIONS FOR THERAPEUTIC PROTEINS 103
Eugenia Kraynov and Martin E. Dowty
7. THE COCKTAIL APPROACH AND ITS UTILITY IN DRUG-DRUGINTERACTION ASSESSMENTS FOR THERAPEUTIC PROTEINS 111
Alexander Jetter and Uwe Fuhr
8. LOGISTIC CONSIDERATIONS IN STUDY DESIGN FOR BIOLOGICDRUG-DRUG INTERACTION ASSESSMENTS 119
Min Zhu and Yu-Nien (Tom) Sun
9. STATISTICAL CONSIDERATIONS IN ASSESSING DRUG-DRUGINTERACTIONS FOR THERAPEUTIC BIOLOGICS 139
Chuanpu Hu and Honghui Zhou
10. SCIENTIFIC PERSPECTIVES ON THERAPEUTIC PROTEINDRUG-DRUG INTERACTION ASSESSMENTS 155
Hong Zhao, Lei Zhang, Kellie Reynolds, and Shiew-MeiHuang
11. DISEASE-DRUG-DRUG INTERACTION ASSESSMENTS FORTOCILIZUMAB--A MONOCLONAL ANTIBODY AGAINST INTERLEUKIN-6RECEPTOR TO TREAT PATIENTS WITH RHEUMATOID ARTHRITIS 191
Xiaoping Zhang and Barbara J. Brennan
12. DRUG-DRUG INTERACTIONS FOR ETANERCEPT--AFUSION PROTEIN 207
Joan Korth-Bradley
13. DRUG INTERACTIONS OF CYTOKINES AND ANTICYTOKINETHERAPEUTIC PROTEINS 215
J. Greg Slatter, Larry C. Wienkers, and Leslie J.Dickmann
14. DRUG INTERACTIONS FOR GROWTH FACTORS AND HORMONES239
Yow-Ming C. Wang and Tarundeep Kakkar
15. DRUG-DRUG INTERACTIONS FOR NUCLEIC ACID-BASEDDERIVATIVES 257
Jian Wang and Hong Zhao
APPENDIX: MONOGRAPHS FOR DRUG-DRUG INTERACTIONS OFTHERAPEUTICS BIOLOGICS 275
Jocelyn Leu, Simone Kasek, Christine Li, Wararat Limothai, DoraBabu Madhura, Chetan Rathi, Sumit Rawal, Josiah Ryman, MargaretThomson, Ashit Trivedi, Honghui Zhou, and Bernd Meibohm
INDEX 351

Über Autor(innen)

HONGHUI ZHOU, PhD, is Senior Scientific Director andJanssen Fellow, Janssen Research & Development, LLC, Johnson& Johnson, where he heads the Pharmacokinetics &Pharma-codynamics Department within Biologics ClinicalPharmacology. Board-certified by the American Board of ClinicalPharmacology and an American College of Clinical PharmacologyFellow, Dr. Zhou has authored more than 150 peer-reviewedscientific papers, book chapters, and conference abstracts inpharmacokinetics, pharmacodynamics, and drug-drug interactions.
BERND MEIBOHM, PhD, is Professor of PharmaceuticalSciences and Associate Dean for Research and Graduate Programs atthe College of Pharmacy, The University of Tennessee Health ScienceCenter. Dr. Meibohm is a Fellow of the American Association ofPharmaceutical Scientists and the American College of ClinicalPharmacology.