Jeffrey S Barrett - Fundamentals of Drug Development

1. Chapter 1
2. Chapter 2
3. Chapter 3
4. Chapter 5
5. Chapter 6
6. Chapter 7
7. Chapter 8
8. Chapter 10
9. Chapter 11
10. Chapter 14
11. Chapter 15
12. Chapter 16
13. Chapter 17
14. Chapter 19
15. Chapter 21
16. Chapter 22
17. Chapter 24
18. Chapter 25

1. Chapter 1
2. Chapter 2
3. Chapter 3
4. Chapter 4
5. Chapter 5
6. Chapter 6
7. Chapter 7
8. Chapter 8
9. Chapter 9
10. Chapter 10
11. Chapter 11
12. Chapter 12
13. Chapter 14
14. Chapter 16
15. Chapter 17
16. Chapter 20
17. Chapter 21
18. Chapter 22
19. Chapter 24
20. Chapter 25

Jeffrey S. Barrett

This edition first published 2022
2022 John Wiley & Sons, Inc.

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Library of Congress CataloginginPublication Data

Names: Barrett, Jeffrey S., author.
Title: Fundamentals of drug development / Jeffrey S. Barrett.
Description: Hoboken, NJ : Wiley, 2022. | Includes bibliographical references and index.
Identifiers: LCCN 2022017493 (print) | LCCN 2022017494 (ebook) | ISBN 9781119691693 (cloth) | ISBN 9781119691709 (adobe pdf) | ISBN 9781119691730 (epub)
Subjects: MESH: Drug Developmentmethods | Technology, Pharmaceuticalmethods | Pharmaceutical Researchmethods
Classification: LCC RM301.25 (print) | LCC RM301.25 (ebook) | NLM QV 745 | DDC 615.1072/4dc23/eng/20220627
LC record available at https://lccn.loc.gov/2022017493LC ebook record available at https://lccn.loc.gov/2022017494

Cover Design: Wiley
Cover Image: pluie_r/Shutterstock

This book is dedicated to former students of the class who repeatedly called for a reference for the lectures. It is also dedicated to the many talented and rigorous scientists who have supported the pharmaceutical industry either directly or in a collaborative manner. It is great work that we have done and still continue to do. Ethical drug development happens every day on the dark side. I continue to believe in the mission to advance science and bring new medicines to patients. I have been blessed with many enlightened friends and collaborators and am forever grateful to those who put pen to paper and help breathe life into this book. Finally, the work would not have been completed without the enduring support from my wife Ann, sons Kyle and Ryan and my parents Carmella and Frank.

Jim Ottinger
Jim Ottinger is a lifelong pharmaceutical industry executive with more than 40 years of strategic regulatory experience, having supported the successful development, approval, and commercialization of a large number of new and generic drugs throughout his career. Mr. Ottinger is currently Executive Vice President of Regulatory and Quality at UroGen Pharma, a small biotech company. Prior to joining UroGen, Jim served as Senior Vice President of Global Regulatory Affairs at Teva Pharmaceutical Industries, Ltd., where he was responsible for global regulatory oversight of Tevas portfolio of branded, generic, and overthecounter products.

Previously, Jim was Vice President of Worldwide Regulatory Affairs of Cephalon, Inc. (acquired by Teva). Earlier in his career, Jim held a variety of senior regulatory positions with Premier Research Group Limited and spent nearly 25 years in regulatory positions of increasing responsibility at Wyeth Research (acquired by Pfizer, Inc.). Jim holds a Bachelor of Science in Pharmacy from the Temple University School of Pharmacy and is a registered pharmacist in the State of Pennsylvania. He lives in North Wales, PA.

Robert Bell
Robert Bell, Ph.D. is President / Owner of Drug and Biotechnology Development LLC, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development. Dr. Bell is a lifelong Gator with Orange and Blue running through his veins, receiving a BS in Chemistry, MS in Food Science and Human Nutrition, and PhD in Pharmaceutics from the University of Florida. His employment history includes CarterWallace, Inc., AL Pharma, UDL Laboratories, Inc., Somerset Pharmaceuticals, Inc., and Barr Laboratories, Inc. Dr. Bell is an Adjunct Professor of Pharmaceutics, National Advisory Board Member and recipient of the Distinguished Alumnus Award from the College of Pharmacy at the University of Florida and former Affiliate Faculty at the College of Pharmacy at Virginia Commonwealth University. Dr. Bell has published and presented extensively and has been issued eleven patents with other patents pending. Research interests include novel formulation development and delivery technologies, pharmaceutical and biomedical analysis, development of vaccines, biosimilars, womens health products, oncology therapeutics, substance abuse, and addiction therapies, pharmaceutical quality, and green ecofriendly chemistry initiatives. Dr. Bell has served in various leadership capacities within the American Association of Pharmaceutical Scientists (AAPS) including Chair of the Analysis and Pharmaceutical Quality (APQ) section, Editorial Advisory Board for the Journal of Pharmaceutical and Biomedical Analysis, reviewer for AAPS PharmSciTech and AAPS Journal, 2006 National Biotechnology Conference Chair, AAPS Executive Council MemberAtLarge (2009), and the 2010 Chair of the Americas for the joint Pharmaceutical Sciences World Congress / FIP / AAPS Annual Meeting and chaired the AAPS Blog Committee. Dr. Bell was a Member of the Council of Experts, General ChaptersBiological Analysis, the Joint Standards Subcommittee, and continues to Chair the Cell Banking Expert Panel for United States Pharmacopeia, participates with the FDA Pharmaceutical Science and Clinical Pharmacology Advisory Committee (Alt), Editorial Advisory Board Member for the