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Improving the Regulatory Review Process, C. Lumley; S.R. Walker


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Автор: C. Lumley; S.R. Walker
Название:  Improving the Regulatory Review Process
ISBN: 9789401072977
Издательство: Springer
Классификация:


ISBN-10: 9401072973
Обложка/Формат: Paperback
Страницы: 172
Вес: 0.29 кг.
Дата издания: 20.09.2011
Серия: Centre for Medicines Research Workshop
Язык: English
Размер: 234 x 156 x 11
Основная тема: Biomedicine
Подзаголовок: Industry and Regulatory Initiatives
Ссылка на Издательство: Link
Рейтинг:
Поставляется из: Германии
Описание: Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible.


Improving the Regulatory Review Process: Assessing Performance and Setting Targets

Автор: N. McAuslane; S.R. Walker
Название: Improving the Regulatory Review Process: Assessing Performance and Setting Targets
ISBN: 9401060428 ISBN-13(EAN): 9789401060424
Издательство: Springer
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Цена: 6986.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: At a time when it is becoming usual for medicines to be developed for a global market and pharmaceutical companies are endeavouring to expedite the drug development process, Regulatory Authorities are concentrating on improving their efficiency and effectiveness.

Pharmacokinetics in Drug Development / Regulatory and Development Paradigms (Volume 2)

Автор: Bonate Peter, Howard Danny
Название: Pharmacokinetics in Drug Development / Regulatory and Development Paradigms (Volume 2)
ISBN: 0971176736 ISBN-13(EAN): 9780971176737
Издательство: Springer
Цена: 22354.00 р.
Наличие на складе: Поставка под заказ.

Описание: These volumes are designed to be the most complete guide to pharmacokinetics (PK) and its role in drug development. Geared toward graduate level students and scientists in the areas of clinical pharmacology and PK, the volumes will fill a gap between the academic science and the practical application of that knowledge in drug development. Volume 1 discusses the role that PK plays in selected clinical study designs, including first-time-in-man, biopharmaceuticals, and special population studies. Volume 2 details the key regulatory and development paradigms in which PK supplements decision-making during drug development.

Gastrointestinal Regulatory Peptides

Автор: David R. Brown; A. Alemayehu; B. Amiranoff; D.L. B
Название: Gastrointestinal Regulatory Peptides
ISBN: 364277816X ISBN-13(EAN): 9783642778162
Издательство: Springer
Рейтинг:
Цена: 18167.00 р.
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Описание: Authored by an array of internationally distinguished scientists, it deals with issues of peptide localization and biosynthesis in gastrointestinal cells, mechanisms of peptide release and inactivation and the nature of peptide receptors.

Pharmaceutical Regulatory Environment

Автор: Reem K. Al-Essa; Mohammed Al-Rubaie; Stuart Walker
Название: Pharmaceutical Regulatory Environment
ISBN: 3319175890 ISBN-13(EAN): 9783319175898
Издательство: Springer
Рейтинг:
Цена: 11878.00 р.
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Описание:

This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients' access to new medicines.

The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region.

Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.

Sphingolipids as Signaling and Regulatory Molecules

Автор: Charles Chalfant; Maurizio Del Poeta
Название: Sphingolipids as Signaling and Regulatory Molecules
ISBN: 1493951564 ISBN-13(EAN): 9781493951567
Издательство: Springer
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Цена: 23058.00 р.
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Описание: This book attempts to analyze the latest discoveries in sphingolipid biology and how the alteration of their metabolism leads to altered signaling events and to the development of pathobiological disorders, such as cancer, cardiovascular diseases, asthma, diabetes, inflammation and infectious diseases.

New Trends in Radiopharmaceutical Synthesis, Quality Assurance, and Regulatory Control

Автор: Ali M. Emran
Название: New Trends in Radiopharmaceutical Synthesis, Quality Assurance, and Regulatory Control
ISBN: 1489906282 ISBN-13(EAN): 9781489906281
Издательство: Springer
Рейтинг:
Цена: 27950.00 р.
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Описание: Proceedings of an American Chemical Society international symposium, held in Washington, DC, August 27-30, 1990

New Trends in Radiopharmaceutical Synthesis, Quality Assurance, and Regulatory Control

Автор: Ali M. Emran
Название: New Trends in Radiopharmaceutical Synthesis, Quality Assurance, and Regulatory Control
ISBN: 0306440350 ISBN-13(EAN): 9780306440359
Издательство: Springer
Рейтинг:
Цена: 41787.00 р.
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Описание: Proceedings of an American Chemical Society international symposium, held in Washington, DC, August 27-30, 1990

Improving the Regulatory Review Process

Автор: C. Lumley; S.R. Walker
Название: Improving the Regulatory Review Process
ISBN: 0792387066 ISBN-13(EAN): 9780792387060
Издательство: Springer
Рейтинг:
Цена: 32004.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible.

Drug Development, Regulatory Assessment, and Postmarketing Surveillance

Автор: William M. Wardell
Название: Drug Development, Regulatory Assessment, and Postmarketing Surveillance
ISBN: 1468440578 ISBN-13(EAN): 9781468440577
Издательство: Springer
Рейтинг:
Цена: 16979.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: Part I, "Drug Assessment and Regulation," is based on the nine sessions of the course that ranged in focus from recent developments in the science of clinical pharmacology and drug development to discussions of whether and how the regulation of drug development can (or should) be harmonized internationally.

Pharmaceutical Regulatory Environment

Автор: Reem K. Al-Essa; Mohammed Al-Rubaie; Stuart Walker
Название: Pharmaceutical Regulatory Environment
ISBN: 3319360108 ISBN-13(EAN): 9783319360102
Издательство: Springer
Рейтинг:
Цена: 8384.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание:

This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients' access to new medicines.

The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region.

Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.



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