Drug-Drug Interactions for Therapeutic Biologics

Description

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.

Table of Contents

Chapter 1: Drug Interactions for Therapeutic Proteins: A Journey Just Beginning
Honghui Zho and Bernd Meibohm

Chapter 2: Pharmacokinetic and Pharmacodynamic-Based Drug Interactions for Therapeutic Proteins
Dan Lu, SandhyaGirish Frank-Peter Theil and Amita Joshi

Chapter 3: Drug Interaction Assessment Strategies: Small Molecules versus Therapeutic Proteins
Shannon Dallas, Carlo Sensenhauser, SouvikChattopadhyay and Jose Silva

Chapter 4: Model-Independent and Modeling-Based Methods to Assess Drug-Drug Interactions for Therapeutic Proteins
Di Wu and Jeffrey Barrett

Chapter 5: Utility of in vitroMethods in Drug-Drug Interaction Assessment and Prediction for Therapeutic Biologics
Theresa Nguyen, Narendra Kishnani, and Raymond Evers

Chapter 6: Use of Animal Models for Projection of Clinical Drug-Drug Interactions for Therapeutic Proteins
Eugenia Kraynov and Martin E. Dowty

Chapter 7: The ‘Cocktail’ Approach and its Utility in Drug-Drug Interaction Assessments for Therapeutic Proteins
Alexander Jetter and UweFuhr

Chapter 8: Logistic Considerations in Study Design for Biologic Drug-Drug Interaction Assessments
Min Zhu and Yu-Nien (Tom) Sun

Chapter 9: Statistical Considerations in Assessing Drug-Drug Interactions for Therapeutic Proteins
Chuanpu Hu and Honghui Zhou

Chapter 10: FDA Perspectives on Therapeutic Protein Drug-Drug Interaction Assessments
Hong Zhao, Lei Zhang, Kellie Reynolds, and Shiew-Mei Huang

Chapter 11: Disease-Drug-Drug Interaction Assessments for Tocilizumab – a Monoclonal Antibody against Interleukin-6 Receptor to Treat Patients with Rheumatoid Arthritis
Xiaoping Zhang and Barbara J. Brennan

Chapter 12: Drug-Drug Interactions for Etanercept – a Fusion Protein
Joan Korth-Bradley

Chapter 13: Drug Interactions of Cytokines and Anti-cytokine Therapeutic Proteins
J. GregSlatter, L.C. Wienkers and Leslie J. Dickmann

Chapter 14: Drug Interactions for Growth Factors and Hormones
Yow-Ming Wang and TarundeepKakkar

Chapter 15: Drug-Drug Interactions for Nucleic Acid-based Derivatives
Jian Wang and Hong Zhao

Appendice: Monographs of Drug-Drug Interactions for Therapeutic Biologics

Author Information

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.