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Quality by Design for Biopharmaceutical Drug Product Development (Record no. 411852)

MARC details
000 -Маркер записи
Контрольное поле постоянной длины 06016nam a22004935i 4500
001 - Контрольный номер
Контрольное поле vtls000556987
005 - Дата корректировки
Контрольное поле 20210922085205.0
007 - Кодируемые данные (физ. описан.)
Контрольное поле постоянной длины cr nn 008mamaa
008 - Кодируемые данные
Контрольное поле постоянной длины 170212s2015 xxu| s |||| 0|eng d
020 ## - Индекс ISBN
ISBN 9781493923168
-- 978-1-4939-2316-8
024 7# - Прочие стандартные номера
Стандартный номер 10.1007/978-1-4939-2316-8
Источник номера doi
035 ## - Системный контрольный номер
Системный контрольный номер to000556987
040 ## - Источник каталогиз.
Служба первич. каталог. Springer
Служба, преобразующая запись Springer
Организация, изменившая запись RU-ToGU
050 #4 - Расстановочный код библ. Конгресса
Классификационный индекс RM1-950
072 #7 - Код предметной/темат. категории
Код предметной/темат. категории MMG
Источник кода bicssc
072 #7 - Код предметной/темат. категории
Код предметной/темат. категории MED071000
Источник кода bisacsh
082 04 - Индекс Дьюи
Индекс Дьюи 615
Номер издания 23
245 10 - Заглавие
Заглавие Quality by Design for Biopharmaceutical Drug Product Development
Физический носитель electronic resource
Ответственность edited by Feroz Jameel, Susan Hershenson, Mansoor A. Khan, Sheryl Martin-Moe.
260 ## - Выходные данные
Место издания New York, NY :
Издательство Springer New York :
-- Imprint: Springer,
Дата издания 2015.
300 ## - Физическое описание
Объем XX, 710 p. 214 illus., 163 illus. in color.
Иллюстрации/тип воспроизводства online resource.
336 ## - Тип содержимого
Тип содержимого text
Content type code txt
Source rdacontent
337 ## - Средство доступа
Средство доступа computer
Media type code c
Source rdamedia
338 ## - Тип носителя
Тип носителя online resource
Carrier type code cr
Source rdacarrier
490 1# - Серия
Заглавие серии AAPS Advances in the Pharmaceutical Sciences Series,
ISSN серии 2210-7371 ;
№ тома 18
505 0# - Примечание о содержании
Содержание 1 Challenges and Opportunities for Biotech Quality by Design -- 2 Lessons Learned From Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program -- 3 Definitions and Scope of Key Elements of QbD -- 4 An Overview of Quality by Design for Drug Product -- 5 Development of Drug Product Formulations: Molecular Design and Early Candidates Screening -- 6 Approaches for Early Developability Assessment of Proteins to Guide Quality by Design of Liquid Formulations -- 7 Application of QbD Principles to Late-stage Formulation Development for Biological Liquid Products -- 8 Application of QbD Principles for Lyophilized Formulation Development -- 9 Drug Substance Frozen Storage and Thawing -- 10 Quality by Design as Applied to Drug Substance Formulation using Ultrafiltration and Diafiltration -- 11 A QbD Approach in the Development and Scale-up of Mixing Processes -- 12 Application of QbD Elements in the Development and Scale-up of a Commercial Filtration Process -- 13 Application of QbD Elements in the Development and Scale-up of Commercial Filling Process -- 14 Lyophilization Process Design and Development Using QbD Principles -- 15 Visible and Subvisible Protein Particle Inspection Within a QbD-based Strategy -- 16 Quality by Design for Distribution of Environmentally Sensitive Pharmaceutical Products -- 17 Quality by Design for Primary Container Components -- 18 Devices and Combination Products for Biopharmaceuticals -- 19 Applicability of QbD for Vaccine Drug Product Development -- 20 Automation and High Throughput Technologies in Biopharmaceutical Drug Product Development with QbD Approaches -- 21 Critical Quality Attributes, Specifications, and Control Strategy -- 22 Multivariate Analysis for Process Understanding, Monitoring, Control and Optimization in Lyophilization Processes -- 23 Using Mathematical Modeling and Prior Knowledge for QbD in Freeze-drying Processes -- 24 Application of Multivariate Statistical Process Monitoring to Lyophilization Process -- 25 Application of PAT in Real-time Monitoring and Controlling of Lyophilization Process -- 26 Product Homogeneity Assessment during Validation of Biopharmaceutical Drug Product Manufacturing Processes -- 27 Application of Quality by Design Principles to the Drug Product Technology Transfer Process -- 28 Regulatory Considerations For Implementation of the QbD Paradigm for Biologics: Laying the Foundation for Product and Process Lifecycle Management.
520 ## - Аннотация
Аннотация 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.
650 #0 - Тематические рубрики
Основная рубрика medicine.
9 (RLIN) 566220
650 #0 - Тематические рубрики
Основная рубрика pharmacology.
9 (RLIN) 460043
650 14 - Тематические рубрики
Основная рубрика Biomedicine.
9 (RLIN) 566246
650 24 - Тематические рубрики
Основная рубрика Pharmacology/Toxicology.
9 (RLIN) 302222
650 24 - Тематические рубрики
Основная рубрика Biomedicine general.
9 (RLIN) 566281
700 1# - Другие авторы
Другие авторы Jameel, Feroz.
Роль лиц editor.
9 (RLIN) 461902
700 1# - Другие авторы
Другие авторы Hershenson, Susan.
Роль лиц editor.
9 (RLIN) 461903
700 1# - Другие авторы
Другие авторы Khan, Mansoor A.
Роль лиц editor.
9 (RLIN) 461904
700 1# - Другие авторы
Другие авторы Martin-Moe, Sheryl.
Роль лиц editor.
9 (RLIN) 461905
710 2# - Другие организации
Организация/юрисдикция SpringerLink (Online service)
9 (RLIN) 143950
773 0# - Источник информации
Название источника Springer eBooks
830 #0 - Заголовок добавочной библ.записи на серию — унифицированное заглавие
Унифицированное заглавие AAPS Advances in the Pharmaceutical Sciences Series,
9 (RLIN) 413469
856 40 - Электронный адрес документа
URL <a href="http://dx.doi.org/10.1007/978-1-4939-2316-8">http://dx.doi.org/10.1007/978-1-4939-2316-8</a>
912 ## - Coursera for Campus: онлайн курсы для ТГУ
Coursera for Campus: онлайн курсы для ТГУ ZDB-2-SBL
999 ## - Системные контрольные номера (Koha)
biblionumber (Koha) 411852

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