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. INDICE: 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 PROTEINS 103 Eugenia Kraynov and Martin E. Dowty 7. THE COCKTAIL APPROACH AND ITS UTILITY IN DRUG–DRUG INTERACTION ASSESSMENTS FOR THERAPEUTIC PROTEINS 111 Alexander Jetter and Uwe Fuhr 8. LOGISTIC CONSIDERATIONS IN STUDY DESIGN FOR BIOLOGIC DRUG–DRUG INTERACTION ASSESSMENTS 119 Min Zhu and Yu–Nien (Tom) Sun 9. STATISTICAL CONSIDERATIONS IN ASSESSING DRUG–DRUG INTERACTIONS FOR THERAPEUTIC BIOLOGICS 139 Chuanpu Hu and Honghui Zhou 10. SCIENTIFIC PERSPECTIVES ON THERAPEUTIC PROTEIN DRUG–DRUG INTERACTION ASSESSMENTS 155 Hong Zhao, Lei Zhang, Kellie Reynolds, and Shiew–Mei Huang 11. DISEASE–DRUG–DRUG INTERACTION ASSESSMENTS FOR TOCILIZUMAB—A MONOCLONAL ANTIBODY AGAINST INTERLEUKIN–6 RECEPTOR TO TREAT PATIENTS WITH RHEUMATOID ARTHRITIS 191 Xiaoping Zhang and Barbara J. Brennan 12. DRUG–DRUG INTERACTIONS FOR ETANERCEPT—A FUSION PROTEIN 207 Joan Korth–Bradley 13. DRUG INTERACTIONS OF CYTOKINES AND ANTICYTOKINE THERAPEUTIC PROTEINS 215 J. Greg Slatter, Larry C. Wienkers, and Leslie J. Dickmann 14. DRUG INTERACTIONS FOR GROWTH FACTORS AND HORMONES 239 Yow–Ming C. Wang and Tarundeep Kakkar 15. DRUG–DRUG INTERACTIONS FOR NUCLEIC ACID–BASED DERIVATIVES 257 Jian Wang and Hong Zhao APPENDIX: MONOGRAPHS FOR DRUG–DRUG INTERACTIONS OF THERAPEUTICS BIOLOGICS 275 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 INDEX 351
- ISBN: 978-1-118-03216-9
- Editorial: Wiley–Blackwell
- Encuadernacion: Cartoné
- Páginas: 378
- Fecha Publicación: 13/08/2013
- Nº Volúmenes: 1
- Idioma: Inglés