Cardiac Safety of Noncardiac Drugs - Practical Guidelines for Clinical Research and Drug Development (Hardcover, 2005 ed.)

It is generally easy to define the efficacy of a new the- peutic agent. However, what is even more difficult and more challenging yet more important is to define its safety when administered to millions of patients with multi-faceted d- eases, co-morbidities, sensitivities and concomitant medi- tions. The commonest cause of new drug discontinuations, cause for disapproval from marketing and removal from the market after approval is a drug's effect on cardiac repolari- tion which is essentially identified by increasing the duration of the QTc interval duration on the standard 12-lead elect- cardiogram (ECG). Cardiac Safety of Noncardiac Drugs: Practical Guide- Joel Morganroth, MD lines for Clinical Research and Drug Development is designed to present the current preclinical, clinical, and re- latory principles to assess the cardiac safety of new drugs based primarily on their effects on the ECG. Practical gu- ance to define cardiac safety at all stages of clinical research and drug development are featured and discussed by inter- tionally recognized experts with academic, industrial, and regulatory experience. Each chapter contains the best ava- able evidence, the author's personal opinions, areas of c- troversy, and future trends. Although some of the areas are highly specialized, this book has been designed for a broad audience ranging from medical and graduate students to cli- cal nurses, clinical trial coordinators, safety officers, data managers, statisticians, regulatory authorities, clinicians, and Ihor Gussak, MD, PhD scientists.

General

Imprint:	HumanaPress
Country of origin:	United States
Release date:	November 2004
First published:	2005
Editors:	Joel Morganroth • Ihor Gussak
Dimensions:	254 x 178 x 26mm (L x W x T)
Format:	Hardcover
Pages:	362
Edition:	2005 ed.
ISBN-13:	978-1-58829-515-6
Categories:	Books > Medicine > Clinical & internal medicine > Cardiovascular medicine Books > Medicine > Other branches of medicine > Pharmacology > General Promotions
LSN:	1-58829-515-X
Barcode:	9781588295156

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