Biosimilar Drug Product Development, Laszlo Endrenyi and Dr. Paul Declerck
Автор: Horne Lena, Horne L. Название: New Product Development in Textiles: Innovation and Production ISBN: 0081014759 ISBN-13(EAN): 9780081014752 Издательство: Elsevier Science Рейтинг: Цена: 28633.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Consumers favour foods with fewer synthetic additives, but products must also be safe to eat and have a sufficiently long shelf-life. Biopreservation, the use of a product’s natural microflora and its antibacterial products for protection against pathogens and spoilage, is a method of growing interest for the safe production of high quality minimally-processed foods. This book provides an essential overview of key topics in this area.Initial chapters review central aspects in food biopreservation, including the identification of new protective cultures and antimicrobial culture components, existing commercial fermentates including nisin and natamycin and the potential of novel fermentates and bacteriophages to improve food safety. Part II concentrates on the use of protective cultures, bacteriocins and bacteriophages to control the carriage of pathogenic microorganisms in food animals and to modulate human gut microflora. Chapters in the final section of the book review biopreservation of different types of foods, including milk and dairy products, fermented meats, fresh seafood and fruit. A review of active packaging for food biopreservation completes the volume.Edited by a leading expert, Protective cultures, antimicrobial metabolites and bacteriophages for food and beverage biopreservation is a fundamental reference for researchers and food industry professionals working to ensure the safety of the food supply.
Описание: Sensory analysis is an important tool in new product development. There has recently been significant development in the methods used to capture sensory perception of a product. Rapid Sensory Profiling Techniques provides a comprehensive review of rapid methods for sensory analysis that can be used as alternatives or complementary to conventional descriptive methods. Part one looks at the evolution of sensory perception capture methods. Part two focuses on rapid methods used to capture sensory perception, and part three covers their applications in new product development and consumer research. Finally, part four explores the applications of rapid methods in testing specific populations.
Описание: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
Автор: Niazi Название: Biosimilarity The Fda Perspective ISBN: 1498750397 ISBN-13(EAN): 9781498750394 Издательство: Taylor&Francis Рейтинг: Цена: 28327.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products.
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.
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