Principles of Process Development and Chemical Development in the Pharmaceutical Industry

This text discusses the functions of Process R&D (research and development), which involves the method of transforming a research synthetic procedure into a plant process and the key aspects of a synthesis that must be considered when scaling up a process. Topics consist of: basic principles of chemical development; techniques for the minimization of by-product impurities; criteria for cost-effective synthesis of enantiopure compounds by resolutions; asymmetric synthesis, and "chiral pool" strategy; synthesis for labeling substances with hydrogen or carbon isotopes; and last, licensing.

Without process R&D there would be no modern pharmaceutical industry. Yet, unlike most other areas of chemistry, it is not taught in schools. As a consequence, the only way for chemists to acquire chemical development expertise is through on-the-job training—a process that can last several years. This book helps shorten the learning curve.

Dr. Oljan Repic clearly explains the goals and basic principles of chemical development. He explores the crucial aspects of a new process that must be considered when scaling up a research synthesis to industrial levels. And, with the help of many fascinating case studies and vignettes, he delineates each phase of the development process. Key topics include:

* Qualities of an ideal process

* Techniques for minimizing impurities

* Criteria for cost-effective synthesis of enantiopure compounds by resolutions

* Asymmetric synthesis and the "chiral pool" strategy

* Synthesis for labeling substances with hydrogen or carbon isotopes

* New drug registration requirements

Writing with candor, wit, and an unflagging enthusiasm for his chosen profession, Dr. Repic vividly chronicles the challenges, disappointments, and rewards experienced by the member of a chemical development team responsible for bringing a lifesaving drug to market. This book is an invaluable reference for professionals as well as an important source of guidance and inspiration for young chemists considering entering the field.

Booknews

An aid to help newcomers to the pharmaceutical industry shorten the time necessary to acquire expertise in chemical development. Discusses the goals and basic principles of chemical development, the crucial aspects of a new process that must be considered when scaling up a research synthesis to industrial levels, and case studies and vignettes to demonstrate each phase of the process. Also describes techniques for minimizing impurities, criteria for the cost-effective synthesis of enantio-pure compounds by resolutions, asymmetric synthesis and the chiral-pool strategy, new drug registration requirements, and other aspects. Annotation c. by Book News, Inc., Portland, Or.