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Library | Item Barcode | Call Number | Material Type | Item Category 1 | Status |
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Searching... | 30000010207650 | RS403 P76 2008 | Open Access Book | Book | Searching... |
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Summary
Summary
As pharmaceutical companies strive to develop safer medicines at a lower cost, they must keep pace with the rapid growth of technology and research methodologies. Defying the misconception of process chemistry as mere scale-up work, Process Chemistry in the Pharmaceutical Industry, Vol. 2: Challenges in an Ever Changing Climate explores novel applications of synthetic, physical, and analytical chemistry in drug discovery and development. It offers an accurate depiction of the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercializing drug candidates.
The second installment in this progressive series, this volumereviews the latest breakthroughs to advance process chemistry, including asymmetric synthesis, crystallization, morphology, enzymatic intervention, green chemistry, macromolecules (monoclonal antibodies, biological molecules, polymers), enantioselectivity, organometallic chemistry, process analytical tools, chemical engineering controls, regulatory compliance, and outsourcing/globalization. It explores new approaches to synthetic processes, examines the latest safety methods and experiment design, and suggests realistic solutions to problems encountered in manufacturing and process development. Significant topics include atom economy, ease of synthesis, instrumentation, automization, quality control, cost considerations, green practices, and future trends.
Jointly edited by the founder/president of Delphian Pharmaceuticals and the director of Chemical R&D at Pfizer, this book brings together contributions byreputed scientists, technologists, engineers, and professors from leading academic institutions, such as the Imperial College, UK, the University of Tokyo, ETH, Switzerland, the International University at Bermen, Germany, and the University of Connecticut, USA, and from principal pharmaceutical companies that include Merck, Bristol Myers Squibb, Pfizer, Novartis, Eli Lilly, Astrazeneca and DSM.
Author Notes
Kumar Gadamasetti, Tamim Braish
Table of Contents
Chapter 1 Process Chemistry in the Pharmaceutical Industry: Challenges in an Ever Changing Climate-An Overview | p. 1 |
Chapter 2 Emerging Trends in Process Chemistry | p. 13 |
Chapter 3 Varenicline: Discovery Synthesis and Process Chemistry Developments | p. 23 |
Chapter 4 The SUTENT Story | p. 49 |
Chapter 5 An Efficient and Scalable Process for the Preparation of a Potent MC4 Receptor Agonist | p. 65 |
Chapter 6 Process Research and Development of LY414197, a 5HT[subscript 2B] Antagonist | p. 89 |
Chapter 7 To Overcome the Hurdles: Coping with the Synthesis of Robalzotan, a Complex Chroman Antidepressant | p. 111 |
Chapter 8 Chiral Amine Synthesis-Strategies, Examples, and Limitations | p. 137 |
Chapter 9 Unnatural Amino Acids | p. 157 |
Chapter 10 The Chemical Development of a Potential Manufacturing Route to the Endothelin Antagonists UK-350,926 and UK-349,862 | p. 181 |
Chapter 11 Cefovecin Sodium: A Single-Dose Long-Acting Antibiotic for Use in Companion Animals | p. 191 |
Chapter 12 The Lithium-Halogen Exchange Reaction in Process Chemistry | p. 205 |
Chapter 13 Oxetan-3-one: Chemistry and Synthesis | p. 217 |
Chapter 14 Well-Defined (NHC)Pd (II) Complexes and Their Use in C-C and C-N Bond-Forming Reactions | p. 231 |
Chapter 15 Toward Truly Efficient Organic Reactions in Water | p. 249 |
Chapter 16 The Chemical Development of the Commercial Route to Sildenafil Citrate | p. 267 |
Chapter 17 Stereoselective Enzymatic Synthesis of Intermediates Used for Antihypertensive, Antiinfective, and Anticancer Compounds | p. 279 |
Chapter 18 Designing Robust Crystallization Processes for Active Pharmaceutical Ingredients-From Art to Science | p. 295 |
Chapter 19 In Situ Mid-Infrared Spectroscopy for Process Development | p. 313 |
Chapter 20 Optimizing an Asymmetric Homologation in a Tandem Asymmetric Homologation-Homoaldol Process | p. 317 |
Chapter 21 Development of Efficient One-Pot Process in the Synthesis of Sitagliptin: Application of Online-Infrared for Kinetic Studies to Probe the Reaction Mechanism | p. 333 |
Chapter 22 Mid-Infrared Monitoring Applications during Development of the Vinyl Ether Formation Step in the Preparation of Aprepitant (Emend) | p. 349 |
Chapter 23 Process Analytical Technology in the Manufacture of Bulk Active Pharmaceuticals-Promise, Practice, and Challenges | p. 361 |
Chapter 24 PEGylation of Biological Macromolecules | p. 383 |
Chapter 25 Microwave Technology in Process Optimization | p. 403 |
Chapter 26 Process Development Considerations for Therapeutic Monoclonal Antibodies in Mammalian Cell Culture | p. 427 |
Chapter 27 Reaction Progress Kinetic Analysis: A Powerful Methodology for Streamlining Pharmaceutical Reaction Steps | p. 455 |
Chapter 28 Trends in Outsourcing | p. 465 |
Chapter 29 Sourcing Pharmaceutical Products in China and India | p. 471 |
Index | p. 481 |