Drug-Drug Interactions for Therapeutic Biologics (eBook)

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.

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