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Informationen zum Autor HONGHUI ZHOU, PhD , is Senior Scientific Director and Janssen Fellow, Janssen Research & Development, LLC, Johnson & Johnson, where he heads the Pharmacokinetics & Pharma-codynamics Department within Biologics Clinical Pharmacology. Board-certified by the American Board of Clinical Pharmacology and an American College of Clinical Pharmacology Fellow, Dr. Zhou has authored more than 150 peer-reviewed scientific papers, book chapters, and conference abstracts in pharmacokinetics, pharmacodynamics, and drug-drug interactions. BERND MEIBOHM, PhD , is Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs at the College of Pharmacy, The University of Tennessee Health Science Center. Dr. Meibohm is a Fellow of the American Association of Pharmaceutical Scientists and the American College of Clinical Pharmacology. Klappentext 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-Drug Interactions for Therapeutic Biologics features contributions from leading international experts in all areas of therapeutic biologics drug development and drug-drug interactions. The authors' contributions reflect a thorough review and analysis of the literature as well as their own firsthand laboratory experience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small molecules and other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment and prediction Risk-based strategies for evaluating biologic drug-drug interactions Strategies to minimize drug-drug interaction risk and mitigate toxic interactions Key regulations governing drug-drug interaction assessments for therapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics is recommended for pharmaceutical and biotechnology scientists, clinical pharmacologists, medicinal chemists, and toxicologists. By enabling these readers to understand how therapeutic biologics may interact with other drugs, the book will help them develop safer, more effective therapeutic biologics. Zusammenfassung Drug-drug interactions (DDIs) occur when a patient is exposed simultaneously to multiple pharmaceuticals, which can result in variations in drug response of the co-administered drugs. Inhaltsverzeichnis PREFACE ix ABOUT THE EDITORS xi CONTRIBUTORS xiii 1. DRUG INTERACTIONS FOR THERAPEUTIC PROTEINS: A JOURNEY JUST BEGINNING 1 Honghui Zhou and Bernd Meibohm 2. PHARMACOKINETIC AND PHARMACODYNAMIC-BASED DRUG INTERACTIONS FOR THERAPEUTIC PROTEINS 5 Dan Lu, Sandhya Girish, Frank-Peter Theil, and Amita Joshi 3. DRUG INTERACTION ASSESSMENT STRATEGIES: SMALL MOLECULES VERSUS THERAPEUTIC PROTEINS 39 Shannon Dallas, Carlo Sensenhauser, Souvik Chattopadhyay, and Jose Silva 4. MODEL-INDEPENDENT AND MODEL-BASED METHODS TO ASSESS DRUG-DRUG INTERACTIONS FOR THERAPEUTIC PROTEINS 63 Di Wu and Jeffrey S. Barrett 5. UTILITY OF IN VITRO METHODS IN DRUG-DRUG INTERACTION ASSESSMENT AND PREDICTION FOR THERAPEUTIC BIOLOGICS 73 Theresa Nguyen, Narendra Kishnani, and Raymond Evers 6. USE OF ANIMAL MODELS FOR PROJECTION OF CLINICAL DRUG-DRUG INTERACTIONS FOR THERAPEUTIC PR...
