If the non-clinical safety study submitted in the dossier of application is conducted in a domestic test facility with the effective GLP Certificate issued by PMDA, the studies conducted in the facility will be considered to be compliant with GLP (see below 'GLP Compliance of submitted data'). As the validation of the antibody used in the study by Gier et al25 was incomplete, we may assume that the convergent results of the four other studies showing absence of GLP1R in human duct epithelial cells correspond more closely to the reality. The present results show definitely that the normal human thyroid, in particular the C cells, do not express GLP1R. The tissues that by far express the highest levels of GLP1R are specific neuroendocrine tumors of the pancreas, the benign insulinomas. As opposed to the small population of GLP1-expressing endocrine cells, the fact that a large part of the pancreatic acinar population expresses GLP1R, even in low density, indicates that there is a considerable amount of nonendocrine GLP1R in the pancreas, for which a physiological role is not yet known.

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