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. 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. 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 vitro Methods 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