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: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1461469155 ISBN-13(EAN): 9781461469155 Издательство: Springer Рейтинг: Цена: 204970.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book highlights the challenges facing quality assurance/quality control (QA/QC) in today`s biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing.
Автор: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1493943995 ISBN-13(EAN): 9781493943999 Издательство: Springer Рейтинг: Цена: 149060.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: In its new edition, this book reviews the challenges facing quality assurance and control (QA/QC) in today`s biopharmaceutical environment, putting into perspective the need for a graded approach to QA/QC from early clinical trials through market approval.
Complexity of Biologics CMC Regulation.- Biopharmaceutics are Not Chemical Drugs.- An Effective CMC Strategy is Possible.- Challenge of Adventitious Agent Control.- Biopharmaceutical Source Materials.- Manufacturing of Biopharmaceutical APIs.- Manufacturing of the Drug Product.- Complex Process-Related Impurity Profiles.- Product Characterization is a Journey.- Priceless Potency (Therapeutic Activity).- Quality Attributes of a Biopharmaceutical.- Designing the Stability Program.- The Art of Setting Specifications.- Demonstrating Product Comparability After Process Changes.- Invaluable CMC-Focused Meetings with Regulatory Authorities.
Автор: Vesper, James L. Название: Quality and GMP Auditing ISBN: 0367400901 ISBN-13(EAN): 9780367400903 Издательство: Taylor&Francis Рейтинг: Цена: 65320.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: More than just a checklist of audit questions, this guidebook contains proven methods and techniques for performing effective audits. Completely covering the four key competencies essential for successful GMP audits, the book explores the rationale behind using audits as a quality tool and explains the audit cycle broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools help readers prepare checklists and standards so audits become more effective, consistent, and standardized.
Автор: Vesper James L Название: Quality And Gmp Auditing: Clear And Simple ISBN: 1574910558 ISBN-13(EAN): 9781574910551 Издательство: Taylor&Francis Рейтинг: Цена: 183750.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: More than just a checklist of audit questions, this guidebook contains proven methods and techniques for performing effective audits. Completely covering the four key competencies essential for successful GMP audits, the book explores the rationale behind using audits as a quality tool and explains the audit cycle broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools help readers prepare checklists and standards so audits become more effective, consistent, and standardized.
Автор: Shen, Cangliang Zhang, Yifan Название: Food microbiology laboratory for the food science student: a practical approach ISBN: 3319583700 ISBN-13(EAN): 9783319583709 Издательство: Springer Рейтинг: Цена: 51230.00 T Наличие на складе: Поставка под заказ. Описание: This book is designed to give students an understanding of the role of microorganisms in food processing and preservation;
Автор: Suzanne Nielsen Название: Food Analysis Laboratory Manual ISBN: 3319441256 ISBN-13(EAN): 9783319441252 Издательство: Springer Рейтинг: Цена: 60550.00 T Наличие на складе: Поставка под заказ. Описание: This third edition laboratory manual was written to accompany Food Analysis, Fifth Edition, by the same author. New to this third edition of the laboratory manual are four introductory chapters that complement both the textbook chapters and the laboratory exercises.
Автор: Lever Название: Kosher and Halal Business Compliance ISBN: 1138065188 ISBN-13(EAN): 9781138065185 Издательство: Taylor&Francis Рейтинг: Цена: 55110.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: There is a pressing need to address kosher & halal markets simultaneously; many companies that have undergone kosher certification indicate that certification is more easily acquired if the company is certified in the first place. The authors characterize expanding kosher & halal markets and explain how businesses can comply with rising demands.
Автор: Le Pinnet Paul Название: Laboratory Scientific Glassblowing: A Practical Training Method ISBN: 1786342421 ISBN-13(EAN): 9781786342423 Издательство: World Scientific Publishing Рейтинг: Цена: 50690.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Related Title: Laboratory Scientific Glassblowing: Advanced Techniques and Glassblowing's Place in History'If you are interested in learning about glassblowing techniques for scientific glassware, then this book is an incredible opportunity to learn from a master glassblower. Much of this information is passed down in person, and to have it available in a book such as this is a very rare opportunity that you should not pass up.'IEEE Electrical Insulation MagazineThis book explains and demonstrates the methods involved in scientific glassblowing. It describes elementary to advanced glass manipulation together with technical information on its safe use and development in the laboratory. Edited by Paul Le Pinnet (MBE), a scientific glassblower with over 50 years' experience in the field, experts in glassblowing are brought together to explain their methods and approaches used to produce a variety of glassware.Laboratory Scientific Glassblowing is a unique project which updates and develops the traditional art of glassblowing and brings it into the 21st century. New skills and materials are introduced, including descriptions of working with fused silica, on laser profile cutting and on the creation of artistic glassware in a scientific setting. Written specifically as a hands-on reference work, this book can be used as a step-by-step practical guide for practitioners and scientists as well as students and apprentices interested in the field.Contributions from: Michael Baumbach, MD of H Baumbach & Co; Paul Rathmill, Enterprise Q; William Fludgate, MD BioChem Glass (app) Ltd; Ian Pearson (Past Chairman BSSG), Editor, BSSG Journal; Gary Coyne, California State University USA; Konstantin Kraft-Poggensee, Former chairman, German Scientific Glassblowing Society; Keith Holden President of the Australian and New Zealand Glassblowing Society; Phil Murray, Churchill Fellow.
Название: Regulatory Toxicology 3E ISBN: 1498780822 ISBN-13(EAN): 9781498780827 Издательство: Taylor&Francis Рейтинг: Цена: 193950.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: With three new chapters on Safety Data Sheet Preparation, Regulatory Requirements for GMOs, and Regulatory Requirements for Tobacco and Marijuana, this practical book provides toxicologists essential information on the regulations that govern their jobs and products. Each chapter covers the historical events that led to the original legislation.
Автор: Le Pinnet Paul Название: Laboratory Scientific Glassblowing: A Practical Training Method ISBN: 1786341972 ISBN-13(EAN): 9781786341976 Издательство: World Scientific Publishing Рейтинг: Цена: 95040.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Related Title: Laboratory Scientific Glassblowing: Advanced Techniques and Glassblowing's Place in History'If you are interested in learning about glassblowing techniques for scientific glassware, then this book is an incredible opportunity to learn from a master glassblower. Much of this information is passed down in person, and to have it available in a book such as this is a very rare opportunity that you should not pass up.'IEEE Electrical Insulation MagazineThis book explains and demonstrates the methods involved in scientific glassblowing. It describes elementary to advanced glass manipulation together with technical information on its safe use and development in the laboratory. Edited by Paul Le Pinnet (MBE), a scientific glassblower with over 50 years' experience in the field, experts in glassblowing are brought together to explain their methods and approaches used to produce a variety of glassware.Laboratory Scientific Glassblowing is a unique project which updates and develops the traditional art of glassblowing and brings it into the 21st century. New skills and materials are introduced, including descriptions of working with fused silica, on laser profile cutting and on the creation of artistic glassware in a scientific setting. Written specifically as a hands-on reference work, this book can be used as a step-by-step practical guide for practitioners and scientists as well as students and apprentices interested in the field.Contributions from: Michael Baumbach, MD of H Baumbach & Co; Paul Rathmill, Enterprise Q; William Fludgate, MD BioChem Glass (app) Ltd; Ian Pearson (Past Chairman BSSG), Editor, BSSG Journal; Gary Coyne, California State University USA; Konstantin Kraft-Poggensee, Former chairman, German Scientific Glassblowing Society; Keith Holden President of the Australian and New Zealand Glassblowing Society; Phil Murray, Churchill Fellow.
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