Drug-drug Interactions for Therapeutic Biologics

by Zhou, Honghui; Meibohm, Bernd

• ISBN13: 9781118032169
• ISBN10: 1118032160
• Edition: 1st
• Format: Hardcover
• Copyright: 2013-06-17
• Publisher: Wiley

Summary

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. Using illustrative case studies and examples, Drug-Drug Interactions for Therapeutic Biologics focuses on the theoretical and practical aspects of DDIs assessments for therapeutic biologics in drug development. The book addresses the complex nature of biologic drug development and DDIs, which are very different from more traditional small molecule drugs, to help readers solve problems of preclinical pharmacology, toxicology, and model-based approaches for biologic drug development and the risk of drug-drug interactions.

Author Biography

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.

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