Active Pharmaceutical Ingredients In Synthesis

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Active Pharmaceutical Ingredients in Synthesis

Author : Anthony J. Burke
Publisher : John Wiley & Sons
ISBN 13 : 3527342419
Total Pages : 450 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Active Pharmaceutical Ingredients in Synthesis by : Anthony J. Burke

Download or read book Active Pharmaceutical Ingredients in Synthesis written by Anthony J. Burke and published by John Wiley & Sons. This book was released on 2018-11-28 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents the most effective catalytic reactions in use today, with a special focus on process intensification, sustainability, waste reduction, and innovative methods This book demonstrates the importance of efficient catalytic transformations for producing pharmaceutically active molecules. It presents the key catalytic reactions and the most efficient catalytic processes, including their significant advantages over compared previous methods. It also places a strong emphasis on asymmetric catalytic reactions, process intensification (PI), sustainability and waste mitigation, continuous manufacturing processes as enshrined by continuous flow catalysis, and supported catalysis. Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development offers chapters covering: Catalysis and Prerequisites for the Modern Pharmaceutial Industry Landscape; Catalytic Process Design - The Industrial Perspective; Hydrogenation, Hydroformylation and Other Reductions; Oxidation; ; Catalytic Addition Reactions; Catalytic Cross-Coupling Reactions; Catalytic Metathesis Reactions; Catalytic Cycloaddition Reactions: Coming Full-Circle; Catalytic Cyclopropanation Reactions; Catalytic C-H insertion Reactions; Phase Transfer Catalysis; and Biocatalysis. -Provides the reader with an updated clear view of the current state of the challenging field of catalysis for API production -Focuses on the application of catalytic methods for the synthesis of known APIs -Presents every key reaction, including Diels-Alder, CH Insertions, Metal-catalytic coupling-reactions, and many more -Includes recent patent literature for completeness Covering a topic of great interest for synthetic chemists and R&D researchers in the pharmaceutical industry, Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development is a must-read for every synthetic chemist working with APIs.

Active Pharmaceutical Ingredients in Synthesis

Author : Anthony J. Burke
Publisher : John Wiley & Sons
ISBN 13 : 3527807241
Total Pages : 382 pages
Book Rating : 4.5/5 (278 download)

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Book Synopsis Active Pharmaceutical Ingredients in Synthesis by : Anthony J. Burke

Download or read book Active Pharmaceutical Ingredients in Synthesis written by Anthony J. Burke and published by John Wiley & Sons. This book was released on 2018-07-20 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents the most effective catalytic reactions in use today, with a special focus on process intensification, sustainability, waste reduction, and innovative methods This book demonstrates the importance of efficient catalytic transformations for producing pharmaceutically active molecules. It presents the key catalytic reactions and the most efficient catalytic processes, including their significant advantages over compared previous methods. It also places a strong emphasis on asymmetric catalytic reactions, process intensification (PI), sustainability and waste mitigation, continuous manufacturing processes as enshrined by continuous flow catalysis, and supported catalysis. Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development offers chapters covering: Catalysis and Prerequisites for the Modern Pharmaceutial Industry Landscape; Catalytic Process Design - The Industrial Perspective; Hydrogenation, Hydroformylation and Other Reductions; Oxidation; ; Catalytic Addition Reactions; Catalytic Cross-Coupling Reactions; Catalytic Metathesis Reactions; Catalytic Cycloaddition Reactions: Coming Full-Circle; Catalytic Cyclopropanation Reactions; Catalytic C-H insertion Reactions; Phase Transfer Catalysis; and Biocatalysis. -Provides the reader with an updated clear view of the current state of the challenging field of catalysis for API production -Focuses on the application of catalytic methods for the synthesis of known APIs -Presents every key reaction, including Diels-Alder, CH Insertions, Metal-catalytic coupling-reactions, and many more -Includes recent patent literature for completeness Covering a topic of great interest for synthetic chemists and R&D researchers in the pharmaceutical industry, Active Pharmaceutical Ingredients in Synthesis: Catalytic Processes in Research and Development is a must-read for every synthetic chemist working with APIs.

Active Pharmaceutical Ingredients

Author : Stanley Nusim
Publisher : CRC Press
ISBN 13 : 1439803390
Total Pages : 456 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Active Pharmaceutical Ingredients by : Stanley Nusim

Download or read book Active Pharmaceutical Ingredients written by Stanley Nusim and published by CRC Press. This book was released on 2016-04-19 with total page 456 pages. Available in PDF, EPUB and Kindle. Book excerpt: To successfully bring an Active Pharmaceutical Ingredient (API) to market, many steps must be followed to ensure compliance with governmental regulations. Active Pharmaceutical Ingredients is an unparalleled guide to the development, manufacturing, and regulation of the preparation and use of APIs globally. Topics include:Safety, efficacy, and envi

Pharmaceutical Biocatalysis

Author : Peter Grunwald
Publisher : CRC Press
ISBN 13 : 1000707571
Total Pages : 567 pages
Book Rating : 4.0/5 (7 download)

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Book Synopsis Pharmaceutical Biocatalysis by : Peter Grunwald

Download or read book Pharmaceutical Biocatalysis written by Peter Grunwald and published by CRC Press. This book was released on 2019-11-07 with total page 567 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides an insight into the future strategies for commercial biocatalysis with a focus on sustainable technologies, together with chemoenzymatic and biotechnological approaches to synthesize various types of approved and new active pharmaceutical ingredients (APIs) via proven and latest synthetic routes using single-step biocatalytic or enzyme cascade reactions. Many of these drugs act as enzyme inhibitors, as discussed in a chapter with a variety of examples. The targeted enzymes are involved in diseases such as different cancers, metastatic and infectious diseases, osteoporosis, and cardiovascular disorders. The biocatalysts employed for API synthesis include hydrolytic enzymes, alcohol dehydrogenases, laccases, imine reductases, reductive aminases, peroxygenases, cytochrome P450 enzymes, polyketide synthases, transaminases, and halogenases. Many of them have been improved with respect to their properties by engineering methods. The book discusses the syntheses of drugs, including alkaloids and antibiotics, non-ribosomal peptides, antimalarial and antidiabetic drugs, prenylated xanthones, antioxidants, and many important (chiral) intermediates required for the synthesis of pharmaceuticals.

Protein Engineering

Author : Huimin Zhao
Publisher : John Wiley & Sons
ISBN 13 : 3527344705
Total Pages : 41 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Protein Engineering by : Huimin Zhao

Download or read book Protein Engineering written by Huimin Zhao and published by John Wiley & Sons. This book was released on 2021-08-23 with total page 41 pages. Available in PDF, EPUB and Kindle. Book excerpt: A one-stop reference that reviews protein design strategies to applications in industrial and medical biotechnology Protein Engineering: Tools and Applications is a comprehensive resource that offers a systematic and comprehensive review of the most recent advances in the field, and contains detailed information on the methodologies and strategies behind these approaches. The authors—noted experts on the topic—explore the distinctive advantages and disadvantages of the presented methodologies and strategies in a targeted and focused manner that allows for the adaptation and implementation of the strategies for new applications. The book contains information on the directed evolution, rational design, and semi-rational design of proteins and offers a review of the most recent applications in industrial and medical biotechnology. This important book: Covers technologies and methodologies used in protein engineering Includes the strategies behind the approaches, designed to help with the adaptation and implementation of these strategies for new applications Offers a comprehensive and thorough treatment of protein engineering from primary strategies to applications in industrial and medical biotechnology Presents cutting edge advances in the continuously evolving field of protein engineering Written for students and professionals of bioengineering, biotechnology, biochemistry, Protein Engineering: Tools and Applications offers an essential resource to the design strategies in protein engineering and reviews recent applications.

Active Pharmaceutical Ingredient Manufacturing

Author : Girish K. Malhotra
Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110702894
Total Pages : 323 pages
Book Rating : 4.1/5 (17 download)

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Book Synopsis Active Pharmaceutical Ingredient Manufacturing by : Girish K. Malhotra

Download or read book Active Pharmaceutical Ingredient Manufacturing written by Girish K. Malhotra and published by Walter de Gruyter GmbH & Co KG. This book was released on 2022-04-19 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book reviews the history of current brand and generic business in pharmaceuticals manufacturing practices. Based on examples, the reader can interpolate, extrapolate and exploit mutual behavior (physical and chemical properties) of chemicals to design and commercialize processes that fulfi ll the demands, also manipulate chemical unit processes and unit operations to reduce/minimize effl uents and lower environmental impact i.e. reduce global warming. Readers will be able to simplify process development, design and commercialize economic manufacturing processes.

Pharmaceutical Biocatalysis

Author : Peter Grunwald
Publisher : CRC Press
ISBN 13 : 1000020940
Total Pages : 801 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis Pharmaceutical Biocatalysis by : Peter Grunwald

Download or read book Pharmaceutical Biocatalysis written by Peter Grunwald and published by CRC Press. This book was released on 2019-06-27 with total page 801 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of the world market of therapeutic enzymes and enzyme inhibitors, rare diseases, orphan drugs, the costs of drug development and therapies, and enzymes in downstream processing of pharmaceuticals. It discusses carbonic anhydrase inhibitors and their multiple drug interactions, carboxylesterase inhibitors for pharmaceutical applications, employment of inhibitors for the treatment of neurodegenerative diseases, use of engineered proteins, bioactive peptides, and fibrinolytic enzymes for thrombolytic therapy, and enzymes important for the design and development of new drugs/drug metabolites such as aldehyde oxidases and cytochrome P450 enzymes and the role the latter play in vascular biology and pathophysiology. The treatment of cancer is explored in connection with enzymatic amino acid deprivation therapies and new drugs that act as chemical degraders of oncogenic proteins. The book also introduces the resistance mechanisms of cancer. Furthermore, it provides an insight into the relationship between pathological conditions of cardiovascular disease and oxidative stress. The text also focuses on the potential use of nanoparticles as carriers for enzymes with medical relevance, computer-aided drug design for the identification of multi-target directed ligands, and the development of improved therapeutics through a glycan-“designer” approach. It concludes with an introduction to the chemoenzymatic synthesis of drugs.

Flow Chemistry for Pharmaceuticals

Author : Rodrigo Octavio Mendonca Alves de Souza
Publisher :
ISBN 13 : 9783110646252
Total Pages : 310 pages
Book Rating : 4.6/5 (462 download)

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Book Synopsis Flow Chemistry for Pharmaceuticals by : Rodrigo Octavio Mendonca Alves de Souza

Download or read book Flow Chemistry for Pharmaceuticals written by Rodrigo Octavio Mendonca Alves de Souza and published by . This book was released on 2022-11-13 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Flow chemistry offers several advantages for a change to more sustainability and flexibility in the production of pharmaceuticals. This book explains the basic concepts of flow chemistry and describes various examples for continuous synthesis and crystallization of active pharmaceutical ingredients. Recently developed techniques but also protocols already applied in industry offer a useful source for researchers in academia and professionals.

Retrosynthesis in the Manufacture of Generic Drugs

Author : Pedro Paulo Santos
Publisher : John Wiley & Sons
ISBN 13 : 1119155533
Total Pages : 434 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Retrosynthesis in the Manufacture of Generic Drugs by : Pedro Paulo Santos

Download or read book Retrosynthesis in the Manufacture of Generic Drugs written by Pedro Paulo Santos and published by John Wiley & Sons. This book was released on 2020-11-09 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offers a compendium of information on retrosynthesis and process chemistry, featuring innovative "reaction maps" showing synthetic routes of some widely used drugs This book illustrates how the retrosynthetic tool is applied in the Pharmaceutical Industry. It considers and evaluates the many viable synthetic routes that can be used by practicing industrialists, guiding readers through the various steps that lead to the "best" processes and the limits encountered if these are put into practice on an industrial scale of seven key Active Pharmaceutical Ingredient (API). It presents an evaluation of the potential each process has for implementation, before merging the two points of view—of retrosynthesis and process chemistry—in order to show how retrosynthetic analysis assists in selecting the most efficient route for an industrial synthesis of a particular compound whilst giving insight into the industrial process. The book also uses some key concepts used by process chemists to improve efficiency to indicate the best route to select. Each chapter in Retrosynthesis in the Manufacture of Generic Drugs Selected Case Studies is dedicated to one drug, with each containing information on: worldwide sales and patent status of the Active Pharmaceutical Ingredient (API); structure analysis and general retrosynthetic strategy of the API; first reported synthesis; critical analysis of the processes which have been developed and comparison of the synthetic routes; lessons learned; reaction conditions for Schemes A to X; chemical "highlights" on key reactions used during the synthesis; and references. Drugs covered include: Gabapentin, Clopidogrel, Citalopram and Escitalopram, Sitagliptin, Ezetimibe, Montelukast, and Oseltamivir. Show how the retrosynthetic tool is used by the Pharmaceutical Industry Fills a gap for a book where retrosynthetic analysis is systematically applied to active pharmaceutical ingredients (APIs) Features analyses and methodologies that aid readers in uncovering practical synthetic routes to other drug substances, whether they be NCEs (New Chemical Entities) or generic APIs (Active Pharmaceutical Ingredients) Presents information from both the patent and academic literature for those who wish to use as a basis for further study and thought Features the use of "reaction maps" which display several synthetic processes in the same scheme, and which allow easy comparisons of different routes that give the same molecule or intermediate. A selection of these maps are available to download from: https://www.wiley.com/go/santos/retrosynthesis Retrosynthesis in the Manufacture of Generic Drugs Selected Case Studies is an ideal book for researchers and advanced students in organic synthetic chemistry and process chemistry. It will also be of great benefit to practitioners in the pharmaceutical industry, particularly new starters, and those new to process chemistry.

Sustainable Flow Chemistry

Author : Luigi Vaccaro
Publisher : John Wiley & Sons
ISBN 13 : 3527689087
Total Pages : 336 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Sustainable Flow Chemistry by : Luigi Vaccaro

Download or read book Sustainable Flow Chemistry written by Luigi Vaccaro and published by John Wiley & Sons. This book was released on 2017-03-14 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: This ready reference not only presents the hot and emerging topic of modern flow chemistry, it is also unique in illustrating the important connection to sustainable chemistry. Focusing on more sustainable methods and applications, the text extensively covers every important field from reaction time optimization to waste minimization, and from safety improvements to microwave applications. In addition, green metrics are presented as a key aspect of the book, helping readers to evaluate the efficiency of flow technologies and their impact on the overall efficiency of a chemical process. An invaluable handbook for every chemist working in the laboratory, whether in academia or industry.

Active Pharmaceutical Ingredients

Author : Stanley Nusim
Publisher : CRC Press
ISBN 13 : 9780824702939
Total Pages : 368 pages
Book Rating : 4.7/5 (29 download)

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Book Synopsis Active Pharmaceutical Ingredients by : Stanley Nusim

Download or read book Active Pharmaceutical Ingredients written by Stanley Nusim and published by CRC Press. This book was released on 2005-05-25 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on the three most critical components that successfully bring an API to market-process development, manufacturing, and governmental regulation and approval-this reference serves as a step-by-step guide to the planning and clear understanding of the bulk manufacturing of APIs. This guide offers current and timely discussions of the process development cycle, design engineering, the approval process, quality control and assurance, and validation, as well as plant manufacturing activities including materials management, maintenance, and safety.

Early Drug Development

Author : Fabrizio Giordanetto
Publisher : John Wiley & Sons
ISBN 13 : 3527801774
Total Pages : 816 pages
Book Rating : 4.5/5 (278 download)

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Book Synopsis Early Drug Development by : Fabrizio Giordanetto

Download or read book Early Drug Development written by Fabrizio Giordanetto and published by John Wiley & Sons. This book was released on 2018-06-15 with total page 816 pages. Available in PDF, EPUB and Kindle. Book excerpt: This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.

Synthetic Methods for Biologically Active Molecules

Author : Elisabetta Brenna
Publisher : John Wiley & Sons
ISBN 13 : 3527665803
Total Pages : 409 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Synthetic Methods for Biologically Active Molecules by : Elisabetta Brenna

Download or read book Synthetic Methods for Biologically Active Molecules written by Elisabetta Brenna and published by John Wiley & Sons. This book was released on 2013-08-29 with total page 409 pages. Available in PDF, EPUB and Kindle. Book excerpt: This useful reference focuses on the currently available toolbox of bio-catalysed reductions of C=O, C=C and formal C=N bonds to show which transformations can be reliably used in manufacturing processes and which still require improvements. Following an introductory chapter, chapters 2-4 present the synthetic strategies that are currently available for the reduction of C=C and C=O bonds and for reductive amination, by means of whole-cell catalysts and isolated enzymes. Chapters 5-7 go on to describe the improvements achieved thus far, illustrating the current versatility of enzymes in organic synthesis. Chapters 8-12 present the improvements brought about by the optimization of reaction conditions, and the use of particular synthetic sequences. The final chapter describes practical applications of bio-reductions for the synthesis of active pharmaceutical ingredients. With its excellent and comprehensive overview, this book will be of great interest to those working in academia and industry. From the contents: * Development of Sustainable Biocatalyzed Reduction Processes for Organic Chemists * Reductases: From Natural Diversity to Biocatalysis and Emerging Enzymatic Activities. * Synthetic Strategies Based on C=C Bioreductions * Synthetic Strategies Based on C=O Bioreductions * Development of Novel Enzymes for the Improved Reduction of C=C Double Bonds * Development of Novel Enzymes for the Improved Reduction of C=O Double Bonds * Synthetic Applications of Aminotransferases * Strategies for Cofactor Regeneration in Biocatalyzed Reductions * Effects of Solvent System and Substrate Loading in Bioreduction * Perspectives in the Use of In-Situ Product Removal (ISPR) Techniques in Bioreductions * Multi-Enzymatic Cascade Reactions Based on Reduction Processes * Relevant Practical Applications of Bioreduction Processes in the Synthesis of Active Pharmaceutical Ingredients

Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients

Author : David J. am Ende
Publisher : John Wiley & Sons
ISBN 13 : 1119285887
Total Pages : 1168 pages
Book Rating : 4.1/5 (192 download)

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Book Synopsis Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients by : David J. am Ende

Download or read book Chemical Engineering in the Pharmaceutical Industry, Active Pharmaceutical Ingredients written by David J. am Ende and published by John Wiley & Sons. This book was released on 2019-03-28 with total page 1168 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the development and manufacturing of pharmaceutical products written for professionals in the industry, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry is a practical book that highlights chemistry and chemical engineering. The book’s regulatory quality strategies target the development and manufacturing of pharmaceutically active ingredients of pharmaceutical products. The expanded second edition contains revised content with many new case studies and additional example calculations that are of interest to chemical engineers. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The active pharmaceutical ingredients book puts the focus on the chemistry, chemical engineering, and unit operations specific to development and manufacturing of the active ingredients of the pharmaceutical product. The drug substance operations section includes information on chemical reactions, mixing, distillations, extractions, crystallizations, filtration, drying, and wet and dry milling. In addition, the book includes many applications of process modeling and modern software tools that are geared toward batch-scale and continuous drug substance pharmaceutical operations. This updated second edition: • Contains 30new chapters or revised chapters specific to API, covering topics including: manufacturing quality by design, computational approaches, continuous manufacturing, crystallization and final form, process safety • Expanded topics of scale-up, continuous processing, applications of thermodynamics and thermodynamic modeling, filtration and drying • Presents updated and expanded example calculations • Includes contributions from noted experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduate students, and professionals in the field of pharmaceutical sciences and manufacturing, the second edition of Chemical Engineering in the Pharmaceutical Industry focuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.

Asymmetric Synthesis of Drugs and Natural Products

Author : Ahindra Nag
Publisher : CRC Press
ISBN 13 : 1315302292
Total Pages : 770 pages
Book Rating : 4.3/5 (153 download)

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Book Synopsis Asymmetric Synthesis of Drugs and Natural Products by : Ahindra Nag

Download or read book Asymmetric Synthesis of Drugs and Natural Products written by Ahindra Nag and published by CRC Press. This book was released on 2018-01-12 with total page 770 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on different techniques of asymmetric synthesis of important compounds, such as drugs and natural products. It gives insightful information on recent asymmetric synthesis by Inorganic, Organic and Enzymatic combinations. It also emphasizes chiral compounds and design of new catalyst for synthesis of compounds.

Active Pharmaceutical Ingredients

Author : Stanley Nusim
Publisher :
ISBN 13 : 9781438003368
Total Pages : 0 pages
Book Rating : 4.0/5 (33 download)

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Book Synopsis Active Pharmaceutical Ingredients by : Stanley Nusim

Download or read book Active Pharmaceutical Ingredients written by Stanley Nusim and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Flow Chemistry in Drug Discovery

Author : Jesus Alcazar
Publisher : Springer Nature
ISBN 13 : 3030855929
Total Pages : 501 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Flow Chemistry in Drug Discovery by : Jesus Alcazar

Download or read book Flow Chemistry in Drug Discovery written by Jesus Alcazar and published by Springer Nature. This book was released on 2021-12-08 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book reviews the challenges and opportunities posed by flow chemistry in drug discovery, and offers a handy reference tool for medicinal chemists interested in the synthesis of biologically active compounds. Prepared by expert contributors, the respective chapters cover not only fundamental methodologies and reactions, such as the application of catalysis, especially biocatalysis and organocatalysis; and non-conventional activation techniques, from photochemistry to electrochemistry; but also the development of new process windows, processes and reactions in drug synthesis. Particular attention is given to automatization and library synthesis, which are of great importance in the pharmaceutical industry. Readers will also find coverage on selected topics of general interest, such as how flow chemistry is contributing to drug discovery R&D in developing countries, and the green character of this enabling technology, for example in the production of raw materials for the pharmaceutical industry from waste. Given its scope, the book appeals to medicinal chemistry researchers working in academia and industry alike, as well as professionals involved in scale-up and drug development.