Defying the misconception of process chemistry as mere scale-up work, this volume explores the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercial drug candidates. It discusses new approaches to synthetic processes, examines the latest safety methods and design experiments, and suggests realistic solutions to problems encountered in manufacturing and process development. Topics include new synthesis methods, instrumentation, automation, quality control, cost considerations, regulatory issues, outsourcing, green practices, and future…mehr
Defying the misconception of process chemistry as mere scale-up work, this volume explores the most up-to-date process research and development methods applied to synthesis, clinical trials, and commercial drug candidates. It discusses new approaches to synthetic processes, examines the latest safety methods and design experiments, and suggests realistic solutions to problems encountered in manufacturing and process development. Topics include new synthesis methods, instrumentation, automation, quality control, cost considerations, regulatory issues, outsourcing, green practices, and future trends. Case studies demonstrate strategies for aggressive drug development programs.
Process Chemistry in the Pharmaceutical Industry: Challenges in an Ever Changing Climate-An Overview. Emerging Trends in Process Chemistry. Varenicline: Discovery Synthesis and Process Chemistry Developments. The SUTENT® Story. An Efficient and Scalable Process for the Preparation of a Potent MC4 Receptor Agonist. Process Research and Development of LY414197, a 5HT2B Antagonist. To Overcome the Hurdles: Coping with the Synthesis of Robalzotan, a Complex Chroman Antidepressant. Chiral Amine Synthesis-Strategies, Examples, and Limitations. The Chemical Development of a Potential Manufacturing Route to the Endothelin Antagonists UK-350,926 and UK-349,862. Cefovecin Sodium: A Single-Dose Long-Acting Antibiotic for Use in Companion Animals. The Lithium-Halogen Exchange Reaction in Process Chemistry. Oxetan-3-one: Chemistry and Synthesis. Well-Defined (NHC)Pd (II) Complexes and Their Use in C-C and C-N Bond-Forming Reactions. Toward Truly Efficient Organic Reactions in Water. The Chemical Development of the Commercial Route to Sildenafil Citrate. Stereoselective Enzymatic Synthesis of Intermediates Used for Antihypertensive, Antiinfective, and Anticancer Compounds. Designing Robust Crystallization Processes for Active Pharmaceutical Ingredients-From Art to Science. In Situ Mid-Infrared Spectroscopy for Process Development. Optimizing an Asymmetric Homologation in a Tandem Asymmetric Homologation-Homoaldol Reaction. Development of Efficient One-Pot Process in the Synthesis of Sitagliptin: Application of Online-Infrared for Kinetic Studies to Probe the Reaction Mechanism. Mid-Infrared Monitoring Applications during Development of the Vinyl Ether Formation Step in the Preparation of Aprepitant (Emend®). Process Analytical Technology in the Manufacture of Bulk Active Pharmaceuticals-Promise, Practice, and Challenges. PEGylation of Biological Macromolecules. Microwave Technology in Process Optimization. Process Development Considerations for Therapeutic Monoclonal Antibodies in Mammalian Cell Culture. Reaction Progress Kinetic Analysis: A Powerful Methodology for Streamlining Pharmaceutical Reaction Steps. Trends in Outsourcing. Sourcing Pharmaceutical Products in China and India. Index.
Process Chemistry in the Pharmaceutical Industry: Challenges in an Ever Changing Climate-An Overview. Emerging Trends in Process Chemistry. Varenicline: Discovery Synthesis and Process Chemistry Developments. The SUTENT® Story. An Efficient and Scalable Process for the Preparation of a Potent MC4 Receptor Agonist. Process Research and Development of LY414197, a 5HT2B Antagonist. To Overcome the Hurdles: Coping with the Synthesis of Robalzotan, a Complex Chroman Antidepressant. Chiral Amine Synthesis-Strategies, Examples, and Limitations. The Chemical Development of a Potential Manufacturing Route to the Endothelin Antagonists UK-350,926 and UK-349,862. Cefovecin Sodium: A Single-Dose Long-Acting Antibiotic for Use in Companion Animals. The Lithium-Halogen Exchange Reaction in Process Chemistry. Oxetan-3-one: Chemistry and Synthesis. Well-Defined (NHC)Pd (II) Complexes and Their Use in C-C and C-N Bond-Forming Reactions. Toward Truly Efficient Organic Reactions in Water. The Chemical Development of the Commercial Route to Sildenafil Citrate. Stereoselective Enzymatic Synthesis of Intermediates Used for Antihypertensive, Antiinfective, and Anticancer Compounds. Designing Robust Crystallization Processes for Active Pharmaceutical Ingredients-From Art to Science. In Situ Mid-Infrared Spectroscopy for Process Development. Optimizing an Asymmetric Homologation in a Tandem Asymmetric Homologation-Homoaldol Reaction. Development of Efficient One-Pot Process in the Synthesis of Sitagliptin: Application of Online-Infrared for Kinetic Studies to Probe the Reaction Mechanism. Mid-Infrared Monitoring Applications during Development of the Vinyl Ether Formation Step in the Preparation of Aprepitant (Emend®). Process Analytical Technology in the Manufacture of Bulk Active Pharmaceuticals-Promise, Practice, and Challenges. PEGylation of Biological Macromolecules. Microwave Technology in Process Optimization. Process Development Considerations for Therapeutic Monoclonal Antibodies in Mammalian Cell Culture. Reaction Progress Kinetic Analysis: A Powerful Methodology for Streamlining Pharmaceutical Reaction Steps. Trends in Outsourcing. Sourcing Pharmaceutical Products in China and India. Index.
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