Pharmaceutical Drug Product Development and Process Optimization,
Автор: Jain N. K. Название: Pharmaceutical Product Development 3Ed (Hb 2018) ISBN: 9386827565 ISBN-13(EAN): 9789386827562 Издательство: CBS India Рейтинг: Цена: 4406.00 р. 6294.00-30% Наличие на складе: Есть (1 шт.)
Название: Pharmaceutical Product Development ISBN: 0367453177 ISBN-13(EAN): 9780367453176 Издательство: Taylor&Francis Рейтинг: Цена: 9492.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: During the last two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner. To meet these ends, pharmaceutical scientists working in the differing areas of pharmacy, pharmaceutics, and pharmacokinetics are collaborating to address physicochemical and biological issues in the early stages of development to avoid problems in later stages. In Vitro-In Vivo Correlation (IVIVC) is a multidisciplinary tool that has been successfully applied in testing the effectiveness of a drug substance. The only comprehensive guide available on IVIVC, this source illustrates the emerging importance of IVIVC in the drug development process, and covers the most recent advances and regulatory perspectives on the role of IVIVC in the pharmaceutical industry.
Автор: Binghe Wang Название: Drug-Drug Interactions in Pharmaceutical Development ISBN: 0471794414 ISBN-13(EAN): 9780471794417 Издательство: Wiley Рейтинг: Цена: 15990.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Drug-Drug Interactions in Pharmaceutical Development comprehensively reviews the relevant science, industrial practice, and regulatory agency positions on drug-drug interactions. It focuses on the evaluation of potential drug-drug interactions, allowing researchers to address risk factors before a drug is put to market.
Описание: This volume focuses on novel therapeutics and strategies for the development of pharmaceutical products, keeping the drug molecule as the central component. It helps to keep readers abreast of knowledge related to current theoretical and practical aspects of pharmaceuticals for the discovery and development of novel therapeutics.
Автор: Nicholas W. Warne; Hanns-Christian Mahler Название: Challenges in Protein Product Development ISBN: 3030080528 ISBN-13(EAN): 9783030080525 Издательство: Springer Рейтинг: Цена: 41925.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.
Автор: Laszlo Endrenyi and Dr. Paul Declerck Название: Biosimilar Drug Product Development ISBN: 1498718795 ISBN-13(EAN): 9781498718790 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Автор: Boyd Sean Название: Pharmaceutical Drug Development ISBN: 1632414686 ISBN-13(EAN): 9781632414687 Издательство: Неизвестно Цена: 22530.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Pharmaceuticals can be defined as drugs that prevent and cure disease. This book on pharmaceutical drug development encompasses an interdisciplinary study of the field that discusses the medicine industry, drug manufacturing processes. This book provides significant information of this discipline to help develop a good understanding of this discipline and related fields. It includes some of the vital pieces of work being conducted across the world, on various topics related to pharmaceutical drug development. For students and researchers in the fields of pharmacology, hospital management, public health policy and pharmaceutical sciences, this book would prove to be very helpful.
Автор: Michael Kinch Название: A Prescription for Change: The Looming Crisis in Drug Development ISBN: 1469647575 ISBN-13(EAN): 9781469647579 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 4703.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The introduction of new medicines has dramatically improved the quantity and quality of individual and public health while contributing trillions of dollars to the global economy. In spite of these past successes--and indeed because of them--our ability to deliver new medicines may be quickly coming to an end. Moving from the beginning of the twentieth century to the present, A Prescription for Change reveals how changing business strategies combined with scientific hubris have altered the way new medicines are discovered, with dire implications for both health and the economy.
To explain how we have arrived at this pivotal moment, Michael Kinch recounts the history of pharmaceutical and biotechnological advances in the twentieth century. Kinch relates stories of the individuals and organizations that built the modern infrastructure that supports the development of innovative new medicines. He shows that an accelerating cycle of acquisition and downsizing is cannibalizing that infrastructure Kinch demonstrates the dismantling of the pharmaceutical and biotechnological research and development enterprises could also provide opportunities to innovate new models that sustain and expand the introduction of newer and better breakthrough medicines in the years to come.
Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.
Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof.
Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms.
The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.
Автор: McCormick, Kate Jr, D. Wylie McVay Название: Pharmaceutical Process Design and Management ISBN: 1138255505 ISBN-13(EAN): 9781138255500 Издательство: Taylor&Francis Рейтинг: Цена: 7961.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.
Описание: Here is a practical guide that not only presents insights into the organization and management of the disciplines involved in chemical process development but also provides basic knowledge of these disciplines, enabling process development practitioners to recognize and assimilate them in their work.
Описание: Pharmaceutics is defined as the design and manufacture of safe and consumable drugs from new chemical entities. This book on pharmaceutics discusses effective drug delivery systems and pharmaceutical formulation for drug manufacture. Relation of drugs to the body as well as the conversion of pure chemical substances into dosage-based prescription drugs is also related to pharmaceutics. Sub-branches of pharmaceutics include pharmaceutical technology, pharmacy sciences and pharmaceutical manufacturing. This book is a valuable compilation of topics, ranging from the basic to the most complex advancements in this field. It will prove useful for students and teachers in the field of pharmacology, medicinal chemistry and drug delivery systems. This book is meant for students who are looking for an elaborated written script on pharmaceutics.
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