Integrated Cardiac Safety: Assessment Methodologies for by J. Rick Turner

By J. Rick Turner

The intense nature of cardiovascular hostile drug reactions taking place in sufferers makes review of a drug's cardiac security profile a excessive precedence in the course of either improvement and post-approval monitoring.В  built-in Cardiac security offers precious suggestions and method for execs assessing cardiac defense of substances all through all phases of the drug's lifestyles, from discovery and improvement via postmarketing learn. This self-contained, reader-friendly textual content is effective to pros within the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, executive officers, and scholars.

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Extra info for Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance

Sample text

In Talbot, J. and Waller, P. ), Stephens ’detection of new adverse drug reactions, 5Ihedition, Chichester, UK: John Wiley & Sons, 3 7 5 4 5 1. , 2004, Development and control of medicines and medical devices, London: Pharmaceutical Press. L, 2006, Clinical trials of drugs and biopharmaceuticals, Boca Raton, FL: CRC/Taylor & Francis. Mann, R. and Andrews, E. ), 2007, Pharmacovigilance, 2"dedition, Chichester, UK: John Wiley & Sons. P. ), 2006, Drug discovery and development: Technology in transition, Philadelphia: Churchill Livingstone/Elsevier.

P The ICH Guidance E 14, Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs, directs clinical trials addressing an investigational drug’s proarrhythmic liability. > Postmarketing surveillance methodologies play a crucial role in monitoring for the occurrence of proarrhythmic and generalized cardiac adverse drug reactions. P In addition to adverse drug reactions that can result from appropriately taken medication, medication errors (errors of prescription, dispensing, and administration) lead to a large number of adverse drug reactions.

On balance, the potential benefit of the drug may not outweigh the risk of experiencing the relatively unlikely but very undesirable side effect. The issue of balancing the probability of benefit with the probability of harm is a central element of clinical practice, and the probability 16 THEIMPORTANCE OF CARDIAC SAFETY ASSESSMENTS of benefit always needs to outweigh the probability of harm. Determining just how much the probability of benefit needs to outweigh the probability of harm in a given situation is the province of the physician’s clinical judgment and the physicianpatient relationship.

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