Cardiac Safety of Noncardiac Drugs: Practical Guidelines for Clinical Research and Drug Development
Available
 
About the Book
Basic and clinical researchers from industry and academia detail the preclinical, clinical, and regulatory principles currently used to assess the cardiac safety of new drugs. The authors explain the parameters of cardiac safety at all stages of clinical research and drug development, including both the preclinical and pharmacogenomic aspects generally and the clinical methodologies and technical aspects for investigational drugs based on cardiac repolarization, as defined by the duration of the QTc interval. Additional chapters comprehensively review the application of electrocardiography in clinical research, the fundamentals of ECG interpretation in clinical trials, the statistical analysis plans for ECG data obtained in formal clinical trials, and the practical interpretation of the ECG results. Highlights include practical guidance on how to conduct a thorough ECG Trial in New Drug Development, how to use new ECG and web based technology in clinical research, and how to follow the new FDA requirements for ECG submissions.
Book Details
ISBN-13: 9781588295156
EAN: 9781588295156
Publisher Date: 01 Feb 2005
Dewey: 616.107
Illustration: Y
LCCN: 2004014055
No of Pages: 362
PrintOnDemand: N
Spine Width: 26 mm
Year Of Publication: 2004
ISBN-10: 158829515X
Publisher: Humana Press
Binding: Hardcover
Height: 261 mm
Language: English
MediaMail: Y
Pagination: 362 pages, biography
Series Title: English
Width: 186 mm