Erio Barale-Thomas - Comment

Comments 1/3 and 2/3 Comment on the scope of the guidance The Guideline Committee of the European Society of Toxicologic Pathologists (ESTP-GC, eurotoxpath.org) finds some discrepancy between the title and introduction (section I) of the guidance, and the sections II and III. The sections II and III give general information on biomarkers and detail how to characterize the performance of a biomarker, but are generally not specific to histology used for biomarker qualification. These important sections should rather be included in a more general guidance, like “Qualification Process for Drug Development Tools” dated October 2010. Alternately, the scope of the guidance could be broadened and histology could be only a section of the guidance on specific disciplines allowing to characterize and validate a given biomarker; this alternative has the preference of the ESTP-GC. Comment on the section IV (A, C-I) These parts are useful reminders which should be part of the quality system of any histology department.