Description
Book SynopsisAn informative look at the intricacies of today's drug development process Once a discovery organization has identified a potential new drug candidate, it is the daunting task of synthetic organic chemists to identify the chemical process suitable for preparation of this compound in a highly regulated environment.
Trade Review"This book will give a lot of pleasure and information to the medicinal chemist, the synthetic organic chemist, and anyone involved in taking a drug candidate to the stage of pharmaceutical formulation." (
Journal of Medicinal Chemistry, December 28, 2006)
‘…this is an excellent book…It is highly recommended to all scientists involved in developing new processes for APIs.’ (Organic Process Research and Development Journal, July 2007)
Table of ContentsContributors.
Preface.
1. Reflections on Process Research II (Edward J. J. Grabowski).
2. Development and Scale-Up of a Heterocyclic Cross-Coupling for the Synthesis of 5-[2-(3-Methyl-3H-imidazol-4-yl)-thieno[3,2-b]pyridine-7-yl] amino-2-methyl-1H-indole (John A. Ragan).
3. Large-Scale Enantioselective Preparation of 2E,7E, 5S,6R,5-Hydroxy-6-methyl-8-phenyl-octa-2,7-dienoic Acid, a Key Fragment for the Formal Total Synthesis of the Anti-tumor Agent Cryptophycin 52 (James Aikins, Tony Y. Zhang, Milton Zmijewski, and Barbara Briggs).
4. Efforts Toward a Commercially Viable Route and Process to the Synthesis of HIV PI GW640385X (John C. Roberts, Roman Davis, Brian D. Doan, Thomas C. Lovelace, Daniel E. Patterson, Frank Roschangar, Barry Sickles, Jennifer F. Toczko, and Ju Yang).
5. Development of an Asymmetric Synthesis of ABT-100 (Albert W. Kruger, Michael J. Rozema, Bridget D. Rohde, Bhadra Shelat, Lakshmi Bhagavatula, James J. Tien, Weijiang Zhang, and Rodger F. Henry)
6. Asymmetric Hydrogenation: A New Route to Pregabalin (Rex Jennings, William S. Kissel, Tung V. Le, Edward Lenoir, Thomas Mulhern, and Robert Wade).
7. Responsibilities of the Process Chemist: Beyond Synthetic Organic Chemistry (Stéphane Caron).
8. Outsourcing—The Challenge of Science, Speed, and Quality (Simone Andler-Burzlaff, Jason Bertola, and Roger E. Marti).
9. Automation and the Changing Face of Process Research in the Pharmaceutical Industry (Edward J. Delaney, Merrill L. Davies, Brent D. Karcher, Victor W. Rosso, A. Erik Rubin, and John J. Venit)
10. Large-Scale Synthesis: An Engineering Perspective (Joseph H. Childers, Jr.)
11. Synthesis and Application of Radioisotopes in Pharmaceutical Research and Development (Larry E. Weaner and David C. Hoerr).
12. Selection of the Drug Form in Exploratory Development (George J. Quallich).
13. Strategies to Achieve Particle Size of Active Pharmaceutical Ingredients (David J. am Ende and Peter R. Rose).
14. Challenges in Early Formulation: Turning Drug Substance into Drug Product (Mark H. Kleinman and Beeah Lee).
15. Intellectual Property and Early Development (Maria I. Shchuka).
Index.
