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Active Pharmaceutical Ingredient Manufacturing
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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
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.
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 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book reviews current brand and generic business in pharmaceuticals manufacturing practices. Based on examples, the reader can interpolate, extrapolate and exploit mutual behavior of chemicals to design and commercialize processes that fulfill the demands, also considering the minimization of the environmental impact on effluents. Readers will be able to simplify process development, design and commercialize economic manufacturing processes.
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:
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498635 Total Pages :169 pages Book Rating :4.3/5 (94 download)
Book Synopsis Regulating Medicines in a Globalized World by : National Academies of Sciences, Engineering, and Medicine
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
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.
Book Synopsis ICH Quality Guidelines by : Andrew Teasdale
Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : David J. am Ende
Download or read book Chemical Engineering in the Pharmaceutical Industry written by David J. am Ende and published by John Wiley & Sons. This book was released on 2019-04-23 with total page 1172 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 Industryf ocuses on the development and chemical engineering as well as operations specific to the design, formulation, and manufacture of drug substance and products.
Book Synopsis Pharmaceutical Process Development by : John Blacker
Download or read book Pharmaceutical Process Development written by John Blacker and published by Royal Society of Chemistry. This book was released on 2011-08-17 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.
Book Synopsis Quality Rules in Active Pharmaceutical Ingredients Manufacture by : John Sharp
Download or read book Quality Rules in Active Pharmaceutical Ingredients Manufacture written by John Sharp and published by Interpharm CRC. This book was released on 2002 with total page 41 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fifth booklet in the best-selling Quality Rules series presents the basic concepts of quality and current Good Manufacturing Practice (cGMP) in a manner easily understood by operators involved in the manufacture and quality assurance of active pharmaceutical ingredients (APIs). Drawing on the guidelines prepared under the ICH and made available by the US FDA, this booklet covers all the cGMP concepts required as training, retraining, and reinforcement resource for workers recently hired into the API manufacturing industry. In his familiar, no-nonsense style, the author explains the rationale of cGMP and the key role played by workers in the production and packaging of pure, safe, and quality APIs.
Book Synopsis Continuous Manufacturing of Pharmaceuticals by : Peter Kleinebudde
Download or read book Continuous Manufacturing of Pharmaceuticals written by Peter Kleinebudde and published by John Wiley & Sons. This book was released on 2017-09-05 with total page 645 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.
Book Synopsis Green Organic Reactions by : Gopinathan Anilkumar
Download or read book Green Organic Reactions written by Gopinathan Anilkumar and published by Springer Nature. This book was released on 2021-03-27 with total page 349 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents important developments and applications of green chemistry, especially in the field of organic chemistry. The chapters give a brief account of green organic reactions in water, green organic reactions using microwave and in solvent-free conditions. In depth discussions on the green aspects of ionic liquids, flow reactions, and recoverable catalysts are provided in this book. An exclusive chapter devoted to green Lewis acid is also included. The potential of supercritical fluids as green solvents in various areas of organic reactions is explained as well. This book will be a valuable reference for beginners as well as advanced researchers interested in green organic chemistry.
Book Synopsis Chemical Engineering in the Pharmaceutical Industry by : Mary T. am Ende
Download or read book Chemical Engineering in the Pharmaceutical Industry written by Mary T. am Ende and published by John Wiley & Sons. This book was released on 2019-04-08 with total page 1435 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to the important chemical engineering concepts for the development of new drugs, revised second edition The revised and updated second edition of Chemical Engineering in the Pharmaceutical Industry offers a guide to the experimental and computational methods related to drug product design and development. The second edition has been greatly expanded and covers a range of topics related to formulation design and process development of drug products. The authors review basic analytics for quantitation of drug product quality attributes, such as potency, purity, content uniformity, and dissolution, that are addressed with consideration of the applied statistics, process analytical technology, and process control. The 2nd Edition is divided into two separate books: 1) Active Pharmaceutical Ingredients (API’s) and 2) Drug Product Design, Development and Modeling. The contributors explore technology transfer and scale-up of batch processes that are exemplified experimentally and computationally. Written for engineers working in the field, the book examines in-silico process modeling tools that streamline experimental screening approaches. In addition, the authors discuss the emerging field of continuous drug product manufacturing. This revised second edition: Contains 21 new or revised chapters, including chapters on quality by design, computational approaches for drug product modeling, process design with PAT and process control, engineering challenges and solutions Covers chemistry and engineering activities related to dosage form design, and process development, and scale-up Offers analytical methods and applied statistics that highlight drug product quality attributes as design features Presents updated and new example calculations and associated solutions Includes contributions from leading experts in the field Written for pharmaceutical engineers, chemical engineers, undergraduate and graduation students, and professionals in the field of pharmaceutical sciences and manufacturing, Chemical Engineering in the Pharmaceutical Industry, Second Edition contains information designed to be of use from the engineer's perspective and spans information from solid to semi-solid to lyophilized drug products.
Book Synopsis Validation of Active Pharmaceutical Ingredients by : Ira R. Berry
Download or read book Validation of Active Pharmaceutical Ingredients written by Ira R. Berry and published by . This book was released on 2001 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations.
Book Synopsis Handbook on Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products by : Ashish Dey
Download or read book Handbook on Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products written by Ashish Dey and published by NIIR PROJECT CONSULTANCY SERVICES. This book was released on 2023-01-05 with total page 18 pages. Available in PDF, EPUB and Kindle. Book excerpt: An active pharmaceutical ingredient (API) is the active substance in a pharmaceutical drug that produces its therapeutic effect. APIs can be synthetic chemicals or natural sources such as plant extracts. APIs are components of drugs, the majority of which are manufactured by pharmaceutical companies. Drugs, on the other hand, are dosage forms that contain an API and are distributed to patients for use. Pharmaceutical products are any compounds used in the medical industry to diagnose, treat, cure, or prevent diseases. These products are typically formulated as drugs, vaccines, biologics, and medical devices, which can either be prescribed by a doctor or bought over-the-counter (OTC). They come in various forms such as tablets, capsules, syrups, ointments, creams, solutions, suspensions, implants, patches, and powders. Pharmaceutical products are manufactured under strict guidelines and must adhere to various regulations such as Good Manufacturing Practices (GMP). The global market for Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products is expected to grow rapidly over the next few years. This growth will be driven by rising demand for improved healthcare services and an increasing number of new treatments. The market for active pharmaceutical ingredients is anticipated to rise at a CAGR of 5.90%. The development in the production of active pharmaceutical ingredients (APIs) as well as the increased incidence of chronic diseases including cancer and cardiovascular conditions are both responsible for the expansion. Government regulations that are supportive of API manufacturing, together with shifting geopolitical conditions, are accelerating market expansion. The pharmaceutical products market has grown steadily in recent years, and is expected to continue to do so. This growth is driven by a number of factors, including increased demand for new drugs, changing disease patterns and aging populations in some countries, as well as the emergence of innovative drugs and technologies. The market is being shaped by the rise of emerging economies and their increasing healthcare needs. This has led to increased investment in drug research and development, as well as an increase in the number of multinational companies setting up operations in various countries. Furthermore, generic drugs are becoming increasingly popular as a way of reducing healthcare costs. Generic drugs are copies of brand-name drugs, which are manufactured by generic drug companies. They offer an effective alternative to branded drugs and are often much cheaper. As a result, generic drugs are increasingly being used in countries across the world, leading to an increase in the global pharmaceutical products market. Overall, the global market for pharmaceutical products and drugs are set to continue to grow in the coming years. New products, innovative technologies and emerging markets will drive growth, and this will bring both opportunities and challenges for the industry. The books' main subjects include Active Pharmaceutical Ingredients (API), Drugs, Aspirin, Paracetamol, IV Fluids, Ointment, Metronidazole, Liquid Glucose, Surgical Cotton, Syrup, Tablet, Excipients, Pharmaceutical Salts with formulations, factory layout, and images of machinery with contact information for suppliers. A thorough guide to manufacturing and business operations in the Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products industry. The Active Pharmaceutical Ingredients (API), Drugs & Pharmaceutical Products manufacturing industry is full with opportunity for producers, traders, and business owners, and this book is your one-stop resource for all the information you require. The only complete manual on the creation of commercial Active Pharmaceutical Ingredients (API), medications, and pharmaceutical products is this one. It offers a wealth of information on how to do things, from concept through equipment acquisition.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :030967218X Total Pages :353 pages Book Rating :4.3/5 (96 download)
Book Synopsis Compounded Topical Pain Creams by : National Academies of Sciences, Engineering, and Medicine
Download or read book Compounded Topical Pain Creams written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-07-21 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.
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.
