Is It Practical to Develop a Class III Antiarrhythmic Agent?
In addressing the question of whether it is practical to develop a Class III antiarrhythmic agent, we confront not only the realities of drug development in the pharmaceutical industry but also the regulatory requirements of the Food and Drug Administration (FDA). To demonstrate the issues involved in a pharmaceutical company’s decision to develop a new drug, we provide a brief overview of the context in which drug development decisions are commonly made and then examine a Class III agent as an example of that process.
KeywordsVentricular Arrhythmia Chemical Entity Antiarrhythmic Agent Developmental Cost Therapeutic Utility
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