<p>PREFACE ix</p> <p>ABOUT THE EDITORS xi</p> <p>CONTRIBUTORS xiii</p> <p><b>1. DRUG INTERACTIONS FOR THERAPEUTIC PROTEINS: A JOURNEY JUST BEGINNING 1</b><br /> <i>Honghui Zhou and Bernd Meibohm</i></p> <p><b>2. PHARMACOKINETIC AND PHARMACODYNAMIC-BASED DRUG INTERACTIONS FOR THERAPEUTIC PROTEINS 5</b><br /> <i>Dan Lu, Sandhya Girish, Frank-Peter Theil, and Amita Joshi</i></p> <p><b>3. DRUG INTERACTION ASSESSMENT STRATEGIES: SMALL MOLECULES VERSUS THERAPEUTIC PROTEINS 39</b><br /> <i>Shannon Dallas, Carlo Sensenhauser, Souvik Chattopadhyay, and Jose Silva</i></p> <p><b>4. MODEL-INDEPENDENT AND MODEL-BASED METHODS TO ASSESS DRUG–DRUG INTERACTIONS FOR THERAPEUTIC PROTEINS 63</b><br /> <i>Di Wu and Jeffrey S. Barrett</i></p> <p><b>5. UTILITY OF IN VITRO METHODS IN DRUG–DRUG INTERACTION ASSESSMENT AND PREDICTION FOR THERAPEUTIC BIOLOGICS 73</b><br /> <i>Theresa Nguyen, Narendra Kishnani, and Raymond Evers</i></p> <p><b>6. USE OF ANIMAL MODELS FOR PROJECTION OF CLINICAL DRUG–DRUG INTERACTIONS FOR THERAPEUTIC PROTEINS 103</b><br /> <i>Eugenia Kraynov and Martin E. Dowty</i></p> <p><b>7. THE COCKTAIL APPROACH AND ITS UTILITY IN DRUG–DRUG INTERACTION ASSESSMENTS FOR THERAPEUTIC PROTEINS 111</b><br /> <i>Alexander Jetter and Uwe Fuhr</i></p> <p><b>8. LOGISTIC CONSIDERATIONS IN STUDY DESIGN FOR BIOLOGIC DRUG–DRUG</b> <b>INTERACTION ASSESSMENTS 119</b><br /> <i>Min Zhu and Yu-Nien (Tom) Sun</i></p> <p><b>9. STATISTICAL CONSIDERATIONS IN ASSESSING DRUG–DRUG INTERACTIONS FOR THERAPEUTIC BIOLOGICS 139</b><br /> <i>Chuanpu Hu and Honghui Zhou</i></p> <p><b>10. SCIENTIFIC PERSPECTIVES ON THERAPEUTIC PROTEIN DRUG–DRUG INTERACTION ASSESSMENTS 155</b><br /> <i>Hong Zhao, Lei Zhang, Kellie Reynolds, and Shiew-Mei Huang</i></p> <p><b>11. DISEASE–DRUG–DRUG INTERACTION ASSESSMENTS FOR TOCILIZUMAB—A MONOCLONAL ANTIBODY AGAINST INTERLEUKIN-6 RECEPTOR TO TREAT PATIENTS WITH RHEUMATOID ARTHRITIS 191</b><br /> <i>Xiaoping Zhang and Barbara J. Brennan</i></p> <p><b>12. DRUG–DRUG INTERACTIONS FOR ETANERCEPT—A FUSION PROTEIN 207</b><br /> <i>Joan Korth-Bradley</i></p> <p><b>13. DRUG INTERACTIONS OF CYTOKINES AND ANTICYTOKINE THERAPEUTIC PROTEINS 215</b><br /> <i>J. Greg Slatter, Larry C. Wienkers, and Leslie J. Dickmann</i></p> <p><b>14. DRUG INTERACTIONS FOR GROWTH FACTORS AND HORMONES 239</b><br /> <i>Yow-Ming C. Wang and Tarundeep Kakkar</i></p> <p><b>15. DRUG–DRUG INTERACTIONS FOR NUCLEIC ACID-BASED DERIVATIVES 257</b><br /> <i>Jian Wang and Hong Zhao</i></p> <p><b>APPENDIX: MONOGRAPHS FOR DRUG-DRUG</b> <b>INTERACTIONS OF THERAPEUTICS BIOLOGICS 275</b><br /> <i>Jocelyn Leu, Simone Kasek, Christine Li, Wararat Limothai, Dora Babu Madhura, Chetan Rathi, Sumit Rawal, Josiah Ryman, Margaret Thomson, Ashit Trivedi, Honghui Zhou, and Bernd Meibohm</i></p> <p>INDEX 351</p>