Why Cardiac Safety Testing is Required for Non Cardiac Drugs

White Paper

Why Cardiac Safety Testing is Required for Non Cardiac Drugs

This white paper explores:

  • The importance of cardiac safety data and why regulators require it
  • Types and the history of cardiac side effects in drug development
  • Common pattern for the unfolding of a new safety concern
  • ICH E14 and Thorough QT or Thorough ECG Trials

More about this white paper:

Currently, FDA and international regulators require that all new chemical entities undergo a variety of safety tests, including assessments of the cardiac safety of the new compound. It is common to hear members of drug development teams question why it is necessary to collect cardiac safety data on their new noncardiac drug, which has no known preclinical or early clinical cardiac toxicities. Many drugs are intended for non-cardiac indications have no obvious link to cardiac side effects. So why the requirement for the collection of cardiac safety data?

The complexity of the human organism is so great that it is unlikely that we will ever be able to completely understand a new drug’s effects simply by preclinical testing and a priori assumptions. The collection of clinical cardiac safety data during drug development will remain our best mechanism for detecting unanticipated cardiovascular side effects before a new drug is widely prescribed and harms hundreds or thousands of patients.

What you’ll learn:

This paper examines the importance of cardiac safety data, including the history of side effects in drug development and how side effects are identified. It also outlines the typical process following the identification of safety concerns, and discusses drugs that have been pulled from the market. You’ll explore methods of cardiac safety testing and why they’re critical to improving patient safety.

This white paper explores:

  • The importance of cardiac safety data and why regulators require it
  • Types and the history of cardiac side effects in drug development
  • Common pattern for the unfolding of a new safety concern
  • ICH E14 and Thorough QT or Thorough ECG Trials

More about this white paper:

Currently, FDA and international regulators require that all new chemical entities undergo a variety of safety tests, including assessments of the cardiac safety of the new compound. It is common to hear members of drug development teams question why it is necessary to collect cardiac safety data on their new noncardiac drug, which has no known preclinical or early clinical cardiac toxicities. Many drugs are intended for non-cardiac indications have no obvious link to cardiac side effects. So why the requirement for the collection of cardiac safety data?

The complexity of the human organism is so great that it is unlikely that we will ever be able to completely understand a new drug’s effects simply by preclinical testing and a priori assumptions. The collection of clinical cardiac safety data during drug development will remain our best mechanism for detecting unanticipated cardiovascular side effects before a new drug is widely prescribed and harms hundreds or thousands of patients.

What you’ll learn:

This paper examines the importance of cardiac safety data, including the history of side effects in drug development and how side effects are identified. It also outlines the typical process following the identification of safety concerns, and discusses drugs that have been pulled from the market. You’ll explore methods of cardiac safety testing and why they’re critical to improving patient safety.



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