International Journal of Pharmaceutical Medicine

, Volume 21, Issue 5, pp 357–361 | Cite as

Safety Pharmacology Assessment

How Early is Too Early (and What is Too Late)?
Current Opinion

Abstract

Safety pharmacology assessments of new drug candidates have recently been described in regulatory guidances (International Conference on Harmonisation [ICH] S7A and ICH S7B) in which the objectives of such studies have been laid out and experimental approaches recommended. It is also clearly stated that when these studies support clinical development, they should be conducted prior to ‘first in man’ studies, in order to protect volunteers and patients from possible inadvertent effects on important physiological functions. Otherwise, the guidelines are flexible on when to conduct safety pharmacology studies.

This article addresses the practical aspects that need to be considered when deciding when to conduct formal safety pharmacology studies. An important aspect is harmonising the requirements for good laboratory practice (GLP) compliance in safety pharmacology studies for regulatory purposes with the advantages inherent in conducting studies as early as possible to be of use in lead optimisation and drug candidate selection. Also of importance is the economic consideration of effective resource utilisation in nonclinical research versus clinical development. Whereas it is attractive to generate safety relevant data early on in research and to use these data for drug candidate selection, this requires a commitment of resource costs. On the other hand, the decision not to generate these data early in the drug development cycle may carry the risk that safety-relevant effects are revealed later in development when significant resources have already been allocated to prepare a given compound for clinical trials. Finding the right balance between resource allocation, satisfying regulatory requirements and the level of risk-taking must be addressed by each sponsor.

Keywords

Drug Candidate Candidate Selection hERG Channel Good Laboratory Practice Lead Optimisation 

Notes

Acknowledgements

No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review.

References

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Copyright information

© Adis Data Information BV 2007

Authors and Affiliations

  1. 1.Boehringer-Ingelheim Pharma GmbH & Co., KGBiberach an der RissGermany
  2. 2.Safety AssessmentMerck & Co., Inc.West PointUSA

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