Safety pharmacology studies are performed for risk analysis, assessment, and management in pharmaceutical development. These studies are aimed at identifying any relevant undesirable pharmacodynamic properties and adverse affects of a substance before it reaches Phase I studies. Safety pharmacology studies can also be used to investigate the mechanism(s) underlying adverse affects. These studies are performed for pharmaceuticals, agrochemicals, cosmetics, food/feed additives and contaminants, novel foods, and biocides.

The core safety pharmacology tests look for effects on the circulatory, respiratory, and central nervous systems. These may be supplemented with studies of the renal system, the gastrointestinal system, or other organ systems depending on the specific compound being tested. These tests are carried out under a rigorous level of scrutiny, typically under the Good Laboratory Practices (GLP) standard.

All countries require that several types of safety pharmacology studies be done before they will grant a company permission to market it in that country. The exact requirements vary from country to country, and some are more demanding than others. This is changing as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH for short) has been working to make it easier to bring drugs to market across the world by standardizing (harmonising) the requirements.

Some links for further reading:
  • The ICH website:
  • The FDA website:
  • The ICH/FDA guidance paper that scopes safety pharmaceutical studies:
  • The Safety Pharmacology Society:
  • American Association for Laboratory Animal Science:
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