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Cardiac Toxicity
Biopharm Knowledge Publishing, March 2008, Pages: 116
Cardiac Toxicity – drugs causing heart muscle, valve damage or potentially fatal arrhythmias in patients - has been implicated in 28% of drug withdrawals in the USA over the last 30 years.
The significance for patients, regulators and the pharmaceutical industry is immense. If cardiac toxicity is discovered during a drug’s development the programme will, almost invariably, be terminated. If cardiac toxicity is discovered after launch then the drug may be withdrawn or new labelling will almost certainly be required.
The consequences for the global pharmaceutical industry can be huge, with major drugs being withdrawn and companies being sued for negligence. But often cardiac events are so rare that they may only be found many years after launch and after thousands, or even millions, of patients have been treated. And when cardiac events do occur the exact mechanism involved may remain a mystery.
This unique report covers all aspects of cardiac toxicity, from physiology and pharmacology to regulation by the FDA and EMEA. It looks at:
- Physiology
- Pharmacology
- Pre-clinical determination of cardiac toxicity
- Determination of potential cardiac toxicity in early phase clinical testing (QTc studies)
- The implications for the clinical trial process
- Regulation
- The commercial implications
It will help you to:
- Understand the physiology and pharmacology of the heart and how cardiac toxicity may be provoked
- See which classes of drugs carry most risk
- Plan for the clinical trial process
- Manage the regulatory process
- Understand the commercial implications
The report is edited by Dr Graham Hughes and includes a chapter on the commercial implications written by Yann Bonduelle and Jo Pisani of PwC.
Key industry and academic figures have also contributed significant chapters to the report:
- Professor Derek Terrar, Professor of Cardiac Electrophysiology, University of Oxford, Fellow in Physiological Sciences (Medicine) Worcester College, Oxford
- Thomas E Donnelly, PhD,Senior Vice President, Quality Assurance and Compliance, Reliance Clinical Research Service
- Daniel B. Goodman, MD, Medical Director, Entelligent Solutions, Inc
- Eileen M. Daniel, Vice President of Operations, Reliance Clinical Research Services
This report, published in association with Oxford Cardiac Pharmacology is essential reading for anyone in biotech, pharmaceuticals or contract research. It will appeal to Corporate Management, Development, R&D, Pre-clinical and Clinical Safety, Regulatory Compliance, Quality, Marketing and Sales. It gives an up to date, authoritative, detailed and clear explanation of the issues surrounding cardiac toxicity and its implications for the pharmaceutical market.
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