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Technology Transfer, Ajay Babu Pazhayattil


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Цена: 12196.00р.
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Автор: Ajay Babu Pazhayattil
Название:  Technology Transfer
ISBN: 9783031322198
Издательство: Springer
Классификация:


ISBN-10: 3031322193
Обложка/Формат: Soft cover
Страницы: 148
Вес: 0.00 кг.
Дата издания: 02.07.2024
Серия: AAPS Introductions in the Pharmaceutical Sciences
Язык: English
Издание: 2023 ed.
Иллюстрации: 55 illustrations, color; 23 illustrations, black and white; xiv, 148 p. 78 illus., 55 illus. in color.
Размер: 235 x 155
Ключевые слова: Pharmacy,Pharmaceutics, Pharmacology
Основная тема: Biomedical and Life Sciences
Подзаголовок: Drug product manufacturing process
Ссылка на Издательство: Link
Рейтинг:
Поставляется из: Германии
Описание: Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance. This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirementsof the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook’s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.
Дополнительное описание: ?Chapter 1: Current Status of Technology Transfer.- Chapter 2: Quality by Design (QbD) Process Design.- Chapter 3: Quality Risk Management (QRM).- Chapter 4: Technology Transfer Process.- Chapter 5: Scaling-Up of Solid Orals: Granulati



Advanced Textbook On Gene Transfer, Gene Therapy And Genetic Pharmacology: Principles, Delivery And Pharmacological And Biomedical Applications Of Nucleotide-based Therapies (Second Edition)

Автор: Scherman Daniel
Название: Advanced Textbook On Gene Transfer, Gene Therapy And Genetic Pharmacology: Principles, Delivery And Pharmacological And Biomedical Applications Of Nucleotide-based Therapies (Second Edition)
ISBN: 1786346877 ISBN-13(EAN): 9781786346872
Издательство: World Scientific Publishing
Рейтинг:
Цена: 33264.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание:

This unique advanced textbook provides a clear and comprehensive overview of gene delivery, gene therapy and genetic pharmacology, with descriptions of the main gene transfer vectors and a set of selected therapeutic applications, along with safety considerations. The second edition features new groundbreaking material on genome editing using the recently discovered CRISPR/Cas9 system and on cancer immunotherapy by CAR-T cells. It also presents the historical milestone of gene therapy application in the field of severe combined immunodeficiency, and other fields of gene therapy and molecular medicine.

The use of gene transfer is exponentially growing in the scientific and medical communities for day-to-day cell biology experiments and swift development of gene therapy, which is already revolutionizing medicine. In this advanced textbook, more than 30 leading scientists come together to explore these topics.

This educational introduction provides the background material needed to further explore the subject as well as relevant research literature. It is an invaluable resource to Master, PhD or MD students, post-doctoral scientists or medical doctors, as well as any scientist wishing to deliver a gene or synthetic nucleotide or develop a gene therapy strategy. The second edition's simple and synthetic content will be of value to any reader interested in the biological and medical revolution derived from the elucidation of the human genome.

Advanced Textbook On Gene Transfer, Gene Therapy And Genetic

Автор: Scherman Daniel
Название: Advanced Textbook On Gene Transfer, Gene Therapy And Genetic
ISBN: 1786347059 ISBN-13(EAN): 9781786347053
Издательство: World Scientific Publishing
Рейтинг:
Цена: 12672.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание:

This unique advanced textbook provides a clear and comprehensive overview of gene delivery, gene therapy and genetic pharmacology, with descriptions of the main gene transfer vectors and a set of selected therapeutic applications, along with safety considerations. The second edition features new groundbreaking material on genome editing using the recently discovered CRISPR/Cas9 system and on cancer immunotherapy by CAR-T cells. It also presents the historical milestone of gene therapy application in the field of severe combined immunodeficiency, and other fields of gene therapy and molecular medicine.

The use of gene transfer is exponentially growing in the scientific and medical communities for day-to-day cell biology experiments and swift development of gene therapy, which is already revolutionizing medicine. In this advanced textbook, more than 30 leading scientists come together to explore these topics.

This educational introduction provides the background material needed to further explore the subject as well as relevant research literature. It is an invaluable resource to Master, PhD or MD students, post-doctoral scientists or medical doctors, as well as any scientist wishing to deliver a gene or synthetic nucleotide or develop a gene therapy strategy. The second edition's simple and synthetic content will be of value to any reader interested in the biological and medical revolution derived from the elucidation of the human genome.

Автор: Gutmann, Felix
Название: Charge Transfer Complexes in Biological Systems
ISBN: 0824799860 ISBN-13(EAN): 9780824799861
Издательство: Taylor&Francis
Рейтинг:
Цена: 56654.00 р.
Наличие на складе: Нет в наличии.

Technology Transfer

Автор: Pazhayattil
Название: Technology Transfer
ISBN: 303132191X ISBN-13(EAN): 9783031321917
Издательство: Springer
Рейтинг:
Цена: 12196.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance. This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirements of the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook’s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.


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