Автор: Rajesh Krishna Название: Dose Optimization in Drug Development Издательство: CRC Press Год: 2006 ISBN: 978-1574448085 Серия: Drugs and the Pharmaceutical Sciences (Book 161) Язык: English Формат: pdf Размер: 23 mb Страниц: 293
Arguably the most difficult aspect of drug development, once proof-of-concept is achieved for a novel mechanism, is defining the “right” dose. Indeed, the question rapidly expands to right for whom? An individual? A population? A specific disease? A unique demographic? The answers can yield a dizzying array of alternatives. Yet pressures to rapidly realize the benefits of a new compound often limit time spent in early development (Phase I/II) when such questions have traditionally been explored. To more efficiently address the problem of defining the optimum dose, new approaches are being applied across the disciplines of drug development.
The present volume, Dose Optimization in Drug Development, in the series Drugs and the Pharmaceutical Sciences, provides a timely overview of emerging knowledge in this field. This knowledge encompasses techniques for exploring individual as well as population dose optimization including the definition of dose-concentration-response relationships, modeling based on these PK/PD relationships, clinical trial simulations, and application of pharmacogenomic principles. One aspect of this research which should not be lost is the requirement for more highly integrated interactions between the clinicians, kineticists, and statisticians addressing these problems.
Handbook of Drug Screening, 2nd Edition Автор: Ramakrishna Seethala, Litao Zhang Название: Handbook of Drug Screening, 2nd Edition Издательство: CRC Press Год: 2009 ISBN: 9781420061680;...
Preclinical Drug Development, 2nd Edition Автор: Mark Rogge and David R. Taft Название: Preclinical Drug Development, 2nd Edition Издательство: CRC Press Год: 2009 ISBN: 9781420084726;...
Preclinical Drug Development Автор: Mark C. Rogge and David R. Taft Название: Preclinical Drug Development Издательство: CRC Press Год: 2005 ISBN: 9781574448825 Серия: Drugs and...
Clinical Drug Trials and Tribulations, 2nd Editon Автор: Allen Cato and Lynda Sutton Название: Clinical Drug Trials and Tribulations, 2nd Editon Издательство: CRC Press Год: 2002 ISBN: 9780824703141...
New Drug Approval Process Автор: Richard A Guarino Название: New Drug Approval Process Издательство: CRC Press Год: 1999 Серия: Drugs and the Pharmaceutical Sciences (Book...
Навигация
Вход на сайт
Реклама
Dose Optimization in Drug Development 
