Integrated cardiac safety
Subtitle: assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance
By: J. Rick Turner, Todd A. Durham.
Contributors: Durham, Todd A.
Publisher: John Wiley & Sons
Published: 2009
Place of publication: Hoboken, N.J
Language: eng
Number of pages: 470
ISBN-13: 9780470229644
Subjects: Cardiovascular toxicology; Heart -- Effect of drugs on; Drugs -- Side effects -- Testing; Drugs -- Safety measures; Cardiovascular Diseases -- prevention & control; Drug Design; Medication Errors; Product Surveillance, Postmarketing -- methods; Safety Management -- methods
Description: The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, governm.
Notes: Includes bibliographical references and index.
Table of contents: title: The importance of cardiac safety assessments; title: The biological basis of adverse drug reactions; title: Cardiac structure and function; title: Cardiac pathophysiology and disease; title: Drug discovery and drug design; title: Nonclinical development; title: The "thorough QT/QTc trial"; title: General safety assessments; title: Therapeutic use trials and meta-analyses; title: Assessment methodologies in nonexperimental postmarketing surveillance; title: Postmarketing proarrhythmic cardiac safety assessments; title: Generalized cardiac safety; title: Medication errors, adherence, and concordance; title: Future directions in drug safety.