Fundamentals of Early Clinical Drug Development : From Synthesis Design to Formulation早期临床药物开发导论：从合成设计到正式配方 rtf 下载 2025 kindle mobi lrf 极速 pdf

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.

Contributors.

Preface.

1. Reflections on Process Research II

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

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

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

5. Development of an Asymmetric Synthesis of ABT-100

6. Asymmetric Hydrogenation: A New Route to Pregabalin

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

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

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

10. Large-Scale Synthesis: An Engineering Perspective

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

12. Selection of the Drug Form in Exploratory Development

13. Strategies to Achieve Particle Size of Active Pharmaceutical Ingredients

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

15. Intellectual Property and Early Development

Index.

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作者介绍：AHMED F. ABDEL-MAGID

　　AHMED F. ABDEL-MAGID is a Senior Research Fellow in Chemical and Pharmaceutical Development at Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

书籍介绍

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.