Formal Definition

The insensitivity of test results to departures from the specified test conditions when conducted in different laboratories or over a range of conditions under which the test method might normally be used. If a test is not robust, it will be difficult to use in a reproducible manner within and between laboratories.

Guidance Document on Good In Vitro Method Practices (GIVIMP)
  • Categories: Pharmacokinetics, Pharmacovigilance