Fundamentals of Early Clinical Drug Development ：From Synthesis Design to Formulation

Publication subTitle ：From Synthesis Design to Formulation

Author： Ahmed F. Abdel-Magid  

Publisher： John Wiley & Sons Inc‎

Publication year： 2006

E-ISBN: 9780470043394

P-ISBN(Hardback):  9780471692782

Subject： R969 clinical pharmacology

Language： ENG

Access to resources Favorite

Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.

Description

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.

Chapter

CONTENTS

pp.：  7 – 9

Contributors

pp.：  9 – 13

Preface

pp.：  13 – 19

1. Reflections on Process Research II

pp.：  19 – 39

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

pp.：  39 – 55

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

pp.：  55 – 71

4. Efforts Toward a Commercially Viable Route and Process to the Synthesis of HIV PI GW640385X

pp.：  71 – 91

5. Development of an Asymmetric Synthesis of ABT-100

pp.：  91 – 103

6. Asymmetric Hydrogenation: A New Route to Pregabalin

pp.：  103 – 119

7. Responsibilities of the Process Chemist: Beyond Synthetic Organic Chemistry

pp.：  119 – 131

8. Outsourcing—The Challenge of Science, Speed, and Quality

pp.：  131 – 147

9. Automation and the Changing Face of Process Research in the Pharmaceutical Industry

pp.：  147 – 181

10. Large-Scale Synthesis: An Engineering Perspective

pp.：  181 – 207

11. Synthesis and Application of Radioisotopes in Pharmaceutical Research and Development

pp.：  207 – 233

12. Selection of the Drug Form in Exploratory Development

pp.：  233 – 265

13. Strategies to Achieve Particle Size of Active Pharmaceutical Ingredients

pp.：  265 – 287

14. Challenges in Early Formulation: Turning Drug Substance into Drug Product

pp.：  287 – 313

15. Intellectual Property and Early Development

pp.：  313 – 337

Index

pp.：  337 – 341

The users who browse this book also browse