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: David Pfister, Lucrece Nicoud, Massimo Morbidelli Название: Continuous Biopharmaceutical Processes: Chromatography, Bioconjugation, and Protein Stability ISBN: 1108420222 ISBN-13(EAN): 9781108420228 Издательство: Cambridge Academ Рейтинг: Цена: 132000.00 T Наличие на складе: Поставка под заказ. Описание: This innovative reference provides a coherent and critical view on the potential benefits of a transition from batch to continuous processes in the biopharmaceutical industry, with the main focus on chromatography. It also covers the key topics of protein stability and protein conjugation, addressing the chemical reaction and purification aspects together with their integration. This book offers a fine balance between theoretical modelling and illustrative case studies, between fundamental concepts and applied examples from the academic and industrial literature. Scientists interested in the design of biopharmaceutical processes will find useful practical methodologies, in particular for single-column and multi-column chromatographic processes.
Автор: Liu Название: Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development ISBN: 1118662318 ISBN-13(EAN): 9781118662311 Издательство: Wiley Рейтинг: Цена: 171020.00 T Наличие на складе: Поставка под заказ. 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: Laszlo Endrenyi and Dr. Paul Declerck Название: Biosimilar Drug Product Development ISBN: 1498718795 ISBN-13(EAN): 9781498718790 Издательство: Taylor&Francis Рейтинг: Цена: 183750.00 T 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: Tingyue Gu Название: Mathematical Modeling and Scale-Up of Liquid Chromatography ISBN: 331916144X ISBN-13(EAN): 9783319161440 Издательство: Springer Рейтинг: Цена: 104480.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Mathematical Modeling and Scale-Up of Liquid Chromatography
Автор: Tingyue Gu Название: Mathematical Modeling and Scale-Up of Liquid Chromatography ISBN: 3319307606 ISBN-13(EAN): 9783319307602 Издательство: Springer Рейтинг: Цена: 78350.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Introduction.- Literature Review.- General Multicomponent Rate Models for Column Liquid Chromatography.- Numerical Solutions and Computer Software with Graphical User Interface.- Mass Transfer Effects.- Interference Effects in Multicomponent Chromatography.- System Peaks In Multicomponent Elution.- Multicomponent Adsorption with Uneven Saturation Capacities.- Modeling of Size Exclusion Chromatography.- Modeling of Ion-Exchange Chromatography with Steric Mass-Action Isotherm.- Modeling of Chromatography with Cored Beads - Advantages And Limitations.- Modeling of Affinity Chromatography.- Modeling of Multicomponent Gradient Elution.- Multicomponent Radial Flow Chromatography.- Parameter Estimation and Parameter Sensitivity Analysis.- Scale-Up Methods and Examples.
Автор: Walker Название: The Management of Chemical Process Development in the Pharmaceutical Industry ISBN: 0470171561 ISBN-13(EAN): 9780470171561 Издательство: Wiley Рейтинг: Цена: 137230.00 T Наличие на складе: Есть у поставщика Поставка под заказ. 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.
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