Ahmed F Abdel-Magid, Stéphane Caron

Drug Development

• Gebundenes Buch

Produktbeschreibung

An 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. Only through a multi-layered chemical process that takes into account such factors as safety, environmental considerations, freedom to operate and cost-effectiveness can researchers begin to refine the drug in terms of quality and yield. This book covers both recent advances in the design and synthesis of new drugs, as well as the myriad other issues facing a new drug candidate as it moves through the development process. Utilizing recent case studies, the authors provide valuable insights into the complexities of the process, from designing new synthetic methodologies and applying new automated techniques for finding optimal reaction conditions to selecting the final drug form and formulation. Both novice and active researchers will appreciate the inclusion of chapters on such diverse topics as: * Cross-coupling methods * Asymmetric synthesis * Automation * Chemical Engineering * Application of radioisotopes * Final form selection * Formulations * Intellectual property A wealth of real-world examples and contributions from leading process scientists, engineers, and related professionals make this book a valuable addition to the scientific literature.

Produktdetails

• Verlag: Turner Publishing Company
• Seitenzahl: 354
• Erscheinungstermin: 1. Oktober 2006
• Englisch
• Abmessung: 240mm x 161mm x 23mm
• Gewicht: 677g
• ISBN-13: 9780471692782
• ISBN-10: 0471692786
• Artikelnr.: 22362166

Autorenporträt

AHMED F. ABDEL-MAGID is a Senior Research Fellow in Chemical and Pharmaceutical Development at Johnson & Johnson Pharmaceutical Research & Development, L.L.C. STÉPHANE CARON is a Director in Chemical Research and Development at Pfizer Global R&D.

Inhaltsangabe

Contributors.

Preface.

1. Reflections on Process Research II (Edward J. J.Grabowski).

2. Development and Scale-Up of a Heterocyclic Cross-Coupling forthe Synthesis of5-[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 KeyFragment for the Formal Total Synthesis of the Anti-tumor AgentCryptophycin 52 (James Aikins, Tony Y. Zhang, Milton Zmijewski,and Barbara Briggs).

4. Efforts Toward a Commercially Viable Route and Process to theSynthesis of HIV PI GW640385X (John C. Roberts, Roman Davis,Brian D. Doan, Thomas C. Lovelace, Daniel E. Patterson, FrankRoschangar, Barry Sickles, Jennifer F. Toczko, and JuYang).

5. Development of an Asymmetric Synthesis of ABT-100 (AlbertW. 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 (RexJennings, William S. Kissel, Tung V. Le, Edward Lenoir, ThomasMulhern, and Robert Wade).

7. Responsibilities of the Process Chemist: Beyond SyntheticOrganic Chemistry (Stéphane Caron).

8. Outsourcing--The Challenge of Science, Speed, andQuality (Simone Andler-Burzlaff, Jason Bertola, and Roger E.Marti).

9. Automation and the Changing Face of Process Research in thePharmaceutical 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 (JosephH. Childers, Jr.)

11. Synthesis and Application of Radioisotopes in PharmaceuticalResearch 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 PharmaceuticalIngredients (David J. am Ende and Peter R. Rose).

14. Challenges in Early Formulation: Turning Drug Substance intoDrug Product (Mark H. Kleinman and Beeah Lee).

15. Intellectual Property and Early Development (Maria I.Shchuka).

Index.

Rezensionen

"This book will give a lot of pleasure and information to themedicinal chemist, the synthetic organic chemist, and anyoneinvolved in taking a drug candidate to the stage of pharmaceuticalformulation." (Journal of Medicinal Chemistry, December 28,2006)

'...this is an excellent book...It is highlyrecommended to all scientists involved in developing new processesfor APIs.' (Organic Process Research and DevelopmentJournal, July 2007)