Cardiac Safety of Noncardiac Drugs: Practical Guidelines for
ISBN: , SKU: , AUTHOR: Morganroth, Joel / Gussak, Ihor, PUBLISHER: Humana Press, 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 sta<strong>gestrong>s of clinical research and drug development, including both the preclinical and phar<strong>macstrong>o<strong>gestrong>nomic aspects <strong>gestrong>nerally 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 <strong>ECGstrong> interpretation in clinical trials, the statistical analysis plans for <strong>ECGstrong> data obtained in formal clinical trials, and the practical interpretation of the <strong>ECGstrong> results. Highlights include practical guidance on how to conduct a thorough <strong>ECGstrong> Trial in New Drug Development, how to use new <strong>ECGstrong> and web based technology in clinical research, and how to follow the new FDA requirements for <strong>ECGstrong> submissions.