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Safety Pharmacology: Guidelines S7A and S7B

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Global Approach in Safety Testing

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 5))

Abstract

Safety pharmacology studies are performed during nonclinical drug development to identify and characterize, in relationship to exposure, potentially undesirable pharmacodynamic effects of a substance on physiological functions. A major objective of these studies is to assess the relevance of these ­pharmacodynamic activities for human safety. The International Conference on Harmonisation (ICH) issued guidelines describing nonclinical safety pharmacology testing strategies to detect effects on core systems, that is, cardiovascular, respiratory, and central nervous systems (ICH S7A), and risk of delaying ventricular repolarization (QT interval prolongation) (ICH S7B). An ICH Expert Working Group (EWG) took on the task of developing safety pharmacology guidelines and achieved step 4 with ICH S7A in 2001. Drug-induced delay in ventricular repolarization (QT interval prolongation) is the topic of a complementary guideline, ICH S7B, which had many of the same EWG members and achieved step 4 in 2005. The present chapter describes these guidelines along with background and context for the final recommendations in the guidelines.

This article reflects the personal opinions of the author and does not necessarily reflect those of the FDA.

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Notes

  1. 1.

    FDA refers to these guidelines as guidances in accordance with FDA’s good guidance practice (62 FR 8961, February 27, 1997).

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Authors and Affiliations

  1. United States Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD, USA

    John E. Koerner Ph.D.

  2. Siegl Pharma Consulting LLC, Blue Bell, PA, USA

    Peter K. S. Siegl

Authors
  1. John E. Koerner Ph.D.
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  2. Peter K. S. Siegl
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Correspondence to John E. Koerner Ph.D. .

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Editors and Affiliations

  1. , Section on Pharmacology, Toxicology, and, Medicines Evaluation Board, Graadt van Roggenweg 500, Utrecht, 3531 AH, Netherlands

    Jan Willem van der Laan

  2. , Drug Safety Testing, Merck Research Laboratories, Sumneytown Pike 770, West Point, 19486, Pennsylvania, USA

    Joseph J. DeGeorge

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© 2013 American Association of Pharmaceutical Scientists

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Koerner, J.E., Siegl, P.K.S. (2013). Safety Pharmacology: Guidelines S7A and S7B. In: van der Laan, J., DeGeorge, J. (eds) Global Approach in Safety Testing. AAPS Advances in the Pharmaceutical Sciences Series, vol 5. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-5950-7_11

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