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Principles of Process Research and Chemical Development in the Pharmaceutical Industry
 
 
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Principles of Process Research and Chemical Development in the Pharmaceutical Industry [Hardcover]

Oljan Repic (Author)
4.0 out of 5 stars  See all reviews (1 customer review)

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Book Description

December 1997 0471165166 978-0471165163 1
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.

Editorial Reviews

From the Publisher

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.

From the Back Cover

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.

Product Details

  • Hardcover: 273 pages
  • Publisher: Wiley-Interscience; 1 edition (December 1997)
  • Language: English
  • ISBN-10: 0471165166
  • ISBN-13: 978-0471165163
  • Product Dimensions: 9.5 x 6.4 x 0.8 inches
  • Shipping Weight: 1 pounds (View shipping rates and policies)
  • Average Customer Review: 4.0 out of 5 stars  See all reviews (1 customer review)
  • Amazon Best Sellers Rank: #2,065,729 in Books (See Top 100 in Books)

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4 of 4 people found the following review helpful:
4.0 out of 5 stars A fundamental introductory guidebook, September 18, 2000
By 
Dr Oliver James Egan (Navan, Co. Meath Ireland) - See all my reviews
This review is from: Principles of Process Research and Chemical Development in the Pharmaceutical Industry (Hardcover)
The book starts by giving the fundamental rundown on all the major points in process development and then moves on to about twenty worked examples taken from industry. It also discusses other essential points such as economy, GMP, and the things that you don't imagine process development to be about, but should. I am relatively new to process development and I find the book very helpful, but I don't know if the book would be very revealing to a more experienced process chemist.
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Inside This Book (learn more)
First Sentence:
What qualities should an ideal plant process have? Read the first page
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
process change control system, enantiopure reagent, racemic synthesis, methanol distillation, phosphonate anion, preferential crystallization, process chemist, chemical development, drug substance, development chemists, asymmetric environment, plant fit, asymmetric synthesis, convergent synthesis, process validation, choline phosphate, other enantiomer, kinetic resolution, aldol reaction, asymmetric syntheses, pyridinium chlorochromate, racemic compound, protecting group, enantiomeric excess, stereoselective synthesis
Key Phrases - Capitalized Phrases (CAPs): (learn more)
Tetrahedron Lett, New York, Acid Derivatives, Tetrahedron Asym, World Pat, Labeled Compounds Radiopharm
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