Principles of Process Research 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.Hier werden die Funktionen von Process R&D diskutiert, die das Umwandeln eines synthetischen Forschungsverfahrens in eine Anlagentechnik betrifft und die wichtigen Aspekte einer Synthese, die bei einer Maßstabsvergrößerung des Verfahrens beachtet werden müssen. Behandelt werden u.a. Themen wie Grundlagen chemischer Entwicklungsarbeit, Techniken zur Minimierung von Verunreinigungen durch Abfallprodukte, Kriterien für kostengerechte Synthese von enantiomer reinen Verbindungen durch Auflösung, asymmetrische Synthese und Lizenzerteilung. Enthalten sind viele praktische und erprobte Beispiele sowie ein Kapitel über Gesetzesvorschriften. (01/98) The Ideal.

Impure Thoughts.

Going All the Way.

Resolutions.

Mirrors.

Au Naturel.

Radiant.

License.

The Future.

Index.

Oljan Repic is the author of Principles of Process Research and Chemical Development in the Pharmaceutical Industry, published by Wiley. 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.