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Efficacy & Safety Pharmacology
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Safety Pharmacology
Safety pharmacology studies provide valuable insight into a drug's adverse effects, as well as a preview of what may be observed clinically. Test data provide essential information about likely side effects on the major physiological systems of the body.
International Conference on Harmonisation (ICH) guidelines for safety pharmacology testing currently fall under two categories:
- ICH S7A, Safety Pharmacology Studies for Human Pharmaceuticals, which provides guidance on requirements for a core battery of tests, including a nonrodent cardiovascular test; rodent conscious respiratory test (e.g., plethysmography); and a rodent CNS behavioral test (e.g., Irwin test). It also provides guidance on when additional or supplemental tests should be conducted.
- ICH S7B, Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals, which provides guidance on requirements for a number of tests, including ion channel and action potential duration assays, to assess a test substance's ability to induce delayed ventricular repolarization. ICH S7B is currently in Step 2 of the ICH process.
Covance has the skills and expertise to undertake a complete assessment of new pharmaceuticals using safety pharmacology tests. We also perform secondary testing to define possible mechanisms by which these side effects arise. This is an exciting and challenging area of safety pharmacology. Each new pharmaceutical tested at Covance is unique in both mechanistic and therapeutic terms, which means we have an opportunity to develop creative testing solutions for every project. |
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