Since biomarkers of safety and efficacy are becoming tools in drug development, it is necessary to determine whether these biomarkers can qualify for applications in clinical trials. Qualification is defined as “a conclusion that the biomarker data submitted support use of the biomarker in drug discovery, drug development or post approval studies and where appropriate, in regulatory decision making” (ICH E-16). A definition of validation was proposed during the workshop. Validation would refer to "establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a biomarker that.
