Integrated cardiac safety : assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance
- نوع فایل : کتاب
- زبان : انگلیسی
- مؤلف : J Rick Turner; Todd A Durham
- ناشر : Hoboken, N.J. : John Wiley & Sons,
- چاپ و سال / کشور: 2009
- شابک / ISBN : 9780470229644
Description
The importance of cardiac safety assessments -- The biological basis of adverse drug reactions -- Cardiac structure and function -- Cardiac pathophysiology and disease -- Drug discovery and drug design -- Nonclinical development -- The thorough QT/QTc trial -- General safety assessments -- Therapeutic use trials and meta-analyses -- Assessment methodologies in nonexperimental postmarketing surveillance -- Postmarketing proarrhythmic cardiac safety assessments -- Generalized cardiac safety -- Medication errors, adherence, and concordance -- Future directions in drug safety.
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.
