Drug Safety Evaluation, Jean-Charles Gautier

Автор: Jiang Qi, Xia H. Amy
Название: Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting
ISBN: 1466555459 ISBN-13(EAN): 9781466555457
Издательство: Taylor&Francis
Рейтинг:
Цена: 17609.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание:

State-of-the-Art Methods for Drug Safety Assessment

Автор: Gad
Название: Drug Safety Evaluation, 2nd Edition
ISBN: 0470253169 ISBN-13(EAN): 9780470253168
Издательство: Wiley
Рейтинг:
Цена: 25186.00 р.
Наличие на складе: Поставка под заказ.

Описание: Government regulatory agencies must approve any drug before it can be sold. This book presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. It also addresses specific approaches to evaluating hazards, including problems and solutions.

Автор: Jean-Charles Gautier
Название: Drug Safety Evaluation
ISBN: 1493971700 ISBN-13(EAN): 9781493971701
Издательство: Springer
Рейтинг:
Цена: 20962.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: Part I: General Toxicology

1. Nonclinical Development of Combination Drugs

18. Evaluation of Embryotoxicity Using

Автор: Shayne C. Gad
Название: Safety Evaluation of Pharmaceuticals and Medical Devices
ISBN: 148998187X ISBN-13(EAN): 9781489981875
Издательство: Springer
Рейтинг:
Цена: 19589.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: The inspiration for this text was the 1988 volume by Alder and Zbinden. Since then, much has changed. But the intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man.

Автор: D.V. Parke; A.N. Worden; J. Marks
Название: The Future of Predictive Safety Evaluation
ISBN: 9401083363 ISBN-13(EAN): 9789401083362
Издательство: Springer
Рейтинг:
Цена: 12157.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: The earliest writings speak of such toxicity and, from the times of ancient Egypt and in the Old Tes- tament, controls have existed[l]. The Royal College of Physicians, for example, was originally established to control the activities of physicians within London.

Автор: A.N. Worden; D.V. Parke; J. Marks
Название: The Future of Predictive Safety Evaluation
ISBN: 9401079366 ISBN-13(EAN): 9789401079365
Издательство: Springer
Рейтинг:
Цена: 12157.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: Reproduction and fetal development in humans and experimental animals may be adversely affected by a wide range of drugs and environmental agents.

Автор: Susan A. Griffiths; C. Lumley
Название: Safety Evaluation of Biotechnologically-derived Pharmaceuticals
ISBN: 9401060436 ISBN-13(EAN): 9789401060431
Издательство: Springer
Рейтинг:
Цена: 13974.00 р.
Наличие на складе: Есть у поставщика Поставка под заказ.

Описание: Considerable investment has been made by both pharmaceutical and biotechnology companies in pharmaceutical products of biotechnology. However, because relatively few of these products have been marketed, lack of relevant experience means that uncertainty still surrounds the most appropriate strategy for their safety evaluation. The 13th CMR International Workshop, held in February 1997, provided the opportunity for regulatory authority and industry experts from Europe, Japan and the USA to share their experiences of designing safety evaluation programmes for specific product classes: colony stimulating factors, growth factors, hormones, interferons, interleukins, monoclonal antibodies for therapeutic use, and gene therapy products. Participants worked together to recommend those studies that should be considered for such safety evaluation, and those that may be unnecessary. These recommendations subsequently made a valuable contribution to the ICH guideline Safety Studies for Biotechnological Products', which was finalised at ICH 4 in Brussels in July 1997. The Workshop proceedings not only describe the recommendations but also provide the reader with an appreciation of the science behind safety evaluation strategies used by experts, the influence of different regulatory systems on these strategies, and the type of data required by both toxicologists and clinicians before they have sufficient confidence to administer pharmaceutical products of biotechnology to humans.