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: Greene Jeremy A. Название: Generic: The Unbranding of Modern Medicine ISBN: 1421414937 ISBN-13(EAN): 9781421414935 Издательство: Johns Hopkins University Press Рейтинг: Цена: 2903.00 р. Наличие на складе: Невозможна поставка.
Описание: Greene`s history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.
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: Fuller, Gordon W. Название: New food product development ISBN: 1439818649 ISBN-13(EAN): 9781439818640 Издательство: Taylor&Francis Рейтинг: Цена: 14545.00 р. Наличие на складе: Поставка под заказ.
Описание:
About the Second Edition:
" a clear and thorough understanding of how the industry as a whole competes, succeeds, and in some instances fails to bring new products to the marketplace . delivers helpful information in a concise, organized style, bringing together diverse elements of the food industry that are all important for a new product introduction into the marketplace. a] should-have reference book for anyone involved in developing new food products working in or with the food industry." Journal of Product Innovation Management, Vol. 23, No. 3
See what 's new in the Third Edition:
Examination of modern marketing techniques such as neuromarketing technology, test market modeling software, and social network marketing
Exploration of economic challenges and how to do more with less to combat rising food commodity prices and lower carbon footprint
Cohesive overview of all aspects of new food product development technologies and advances
In-depth review of techniques of new product development and simulated test markets
Expanded discussion of the problems specific to product development for the food service industry
With new material highlighting the latest trends and science in marketing and electronic communication and their combined effect on market research, New Food Product Development: From Concept to Marketplace, Third Edition, describes stages of development in detail, beginning with sources of ideas and moving through development, final screening, and introduction into the marketplace. Drawing on his extensive experience in new food product development, the author outlines ways a company can organize for new product development and optimize available resources. He focuses on the roles, functions, and interactions of the members of the food product development team, other company departments, and outside resources in the food product development process. A well-grounded, broad perspective in the fundamentals of the new food development process in industry, this new edition of a bestseller clearly delineates cost-effective best practices for bringing new products to market.
Автор: Greene Jeremy A. Название: Generic ISBN: 142142164X ISBN-13(EAN): 9781421421643 Издательство: Неизвестно Рейтинг: Цена: 5897.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Greene`s history sheds light on the controversies shadowing the success of generics: problems with the generalizability of medical knowledge, the fragile role of science in public policy, and the increasing role of industry, marketing, and consumer logics in late-twentieth-century and early twenty-first century health care.
Автор: Feroz Jameel; Susan Hershenson; Mansoor A. Khan; S Название: Quality by Design for Biopharmaceutical Drug Product Development ISBN: 1493923153 ISBN-13(EAN): 9781493923151 Издательство: Springer Рейтинг: Цена: 30745.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development.
Автор: Uday B. Kompella; Henry F. Edelhauser Название: Drug Product Development for the Back of the Eye ISBN: 146142819X ISBN-13(EAN): 9781461428190 Издательство: Springer Рейтинг: Цена: 32651.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Selection of Drug Delivery Approaches for the Back of the Eye: Opportunities and Unmet Needs.- Microdialysis for Vitreal Pharmacokinetics.- Fluorophotometry for Pharmacokinetic Assessment.- Systemic Route for Retinal Drug Delivery: Role of the Blood-Retinal Barrier.- Topical Drug Delivery to the Back of the Eye.- Principles of Retinal Drug Delivery from Within the Vitreous.- Transscleral Drug Delivery.- Suprachoroidal and Intrascleral Drug Delivery.- Advances in Biodegradable Ocular Drug Delivery Systems.- Microparticles as Drug Delivery Systems for the Back of the Eye.- Nanotechnology and Nanoparticles.- Hydrogels for Ocular Posterior Segment Drug Delivery.- Refillable Devices for Therapy of Ophthalmic Diseases.- Targeted Drug Delivery to the Eye Enabled by Microneedles.- Ocular Iontophoresis.- Drug and Gene Therapy Mediated by Physical Methods.- Protein Drug Delivery and Formulation Development.- Drug Suspension Development for the Back of the Eye.- Regulatory Considerations in Product Development for Back of the Eye.- Clinical Endpoints for Back of the Eye Diseases.- Druggable Targets and Therapeutic Agents for Disorders of the Back of the Eye.- Development of Bile Acids as Anti-Apoptotic and Neuroprotective Agents in Treatment of Ocular Disease.
Автор: Lars Bohlin; Jan G. Bruhn Название: Bioassay Methods in Natural Product Research and Drug Development ISBN: 9401060193 ISBN-13(EAN): 9789401060196 Издательство: Springer Рейтинг: Цена: 26122.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Bioassay Methods in Natural Product Research and Drug Development contains the proceedings from the Phytochemical Society of Europe`s very successful symposium on this topic, held August 24-27, 1997 in Uppsala, Sweden.
Автор: Lars Bohlin; Jan G. Bruhn Название: Bioassay Methods in Natural Product Research and Drug Development ISBN: 079235480X ISBN-13(EAN): 9780792354802 Издательство: Springer Рейтинг: Цена: 26122.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Bioassay Methods in Natural Product Research and Drug Development contains the proceedings from the Phytochemical Society of Europe`s very successful symposium on this topic, held August 24-27, 1997 in Uppsala, Sweden.
Автор: Feroz Jameel; Susan Hershenson; Mansoor A. Khan; S Название: Quality by Design for Biopharmaceutical Drug Product Development ISBN: 1493951521 ISBN-13(EAN): 9781493951529 Издательство: Springer Рейтинг: Цена: 30745.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
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