Overcoming Obstacles in Drug Discovery and Development: Surmounting the Insurmountable

ISBN-13: 9780128171349 / Angielski / Miękka / 2023

Kan He; Paul F. Hollenberg; Larry C. Wienkers

Spis treści

Preface

Kan He, Paul Frederick Hollenberg and Larry C. Wienkers

1. Learning to think critically

Brian Barnes

2. Leveraging ADME/PK information to enable knowledge-driven decisions in drug discovery and development

Larry C. Wienkers

3. Systems biology and data science in research and translational medicine

Karim Azer, Jeff S. Barrett, Mirjam Trame and Cynthia J. Musante

4. Drug Discovery and Development of ASO

Brooke Rock

5. Drug development of covalent Inhibitors

Upendra P. Dahal and Jan L. Wahlstrom

6. Denosumab: dosing and drug interaction challenges on the path to approval

Graham Jang

7. Discovery and development of ADCs: obstacles and opportunities

Hsuan Ping Chang, Yuen Kiu Cheung and Dhaval K. Shah

8. How to reduce risk of drug induced liver toxicity from the beginning

Jinping Gan, Kan He and W. Griffith Humphreys

9. Optimization for small volume of distribution leading to the discovery of apixaban

Kan He

10. Design, conduct, and interpretation of human mass balance studies and strategies for assessing metabolites-in-safety testing (MIST) in drug development

Simon G. Wong and Shuguang Ma

11. Conquering low oral bioavailability issues in drug discovery and development

Timothy J. Carlson

12. Case study of OATP1B DDI assessment and challenges in drug discovery and development-real-life examples

Hong Shen, Jinping Gan and Giridhar S. Tirucherai

13. Investigating the link between drug metabolism and toxicity

W. Griffith Humphreys

14. Overcoming nephrotoxicity in rats: the successful development and registration of the HIV-AIDS drug efavirenz (Sustiva®)

D.D. Christ

15. Disproportionate drug metabolites: challenges and solutions

Chandra Prakash

16. Disposition and metabolism of ozanimod-Surmounting the unanticipated challenge late in the development

Deepak Dalvie and Sekhar Surapaneni

17. Application of reaction phenotyping to address pharmacokinetic variability in patient populations

Robert S. Foti, Joseph M. Roesner and Joshua T. Pearson

18. Kyprolis (carfilzomib) (approved): a covalent drug with high extrahepatic clearance via peptidase cleavage and epoxide hydrolysis

Zhengping Wang, Jinfu Yang an Christopher Kirk

19. Engaging diversity in research: Does your drug work in overlooked populations?

Karen E. Brown and Erica L. Woodahl

20. PBPK modeling for Early clinical study decision making

Arian Emami Riedmaier

21. Integrated pharmacokinetic/pharmacodynamic/efficacy analysis in oncology: importance of pharmacodynamic/efficacy relationships

Harvey Wong

22. Predicting unpredictable human pharmacokinetics: Case studies from the trenches of drug discovery

Zheng Yang

23. Esmolol (soft drug design)

Paul W. Erhardt