Toxicologic Pathology

 

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This version was published on February 1, 2008
Toxicologic Pathology, Vol. 36, No. 2, 250-255 (2008)
DOI: 10.1177/0192623307312700

Invited Review

Evaluation of the Cynomolgus Monkey Stomach: Recommendations for Standard Sampling Procedures in Nonclinical Safety Studies

Justin D. Vidal, Rosanna C. Mirabile and Heath C. Thomas

GlaxoSmithKline, King of Prussia, Pennsylvania, USA

Correspondence: Address correspondence to: Justin D. Vidal, GlaxoSmithKline, 709 Swedeland Rd. UE0376, King of Prussia, PA 19406–0939, USA; e-mail: justin.2.vidal{at}gsk.com.

The cynomolgus macaque is the most commonly used nonhuman primate in nonclinical toxicity testing, but the macroscopic and microscopic anatomy of the stomach in the cynomolgus macaque is poorly described. To develop a reliable sampling method for histologic evaluation of the cynomolgus macaque stomach in regulatory toxicity studies, the stomachs of control animals were prospectively evaluated using an extensive sectioning pattern. The stomach of the cynomolgus macaque differs from that described for the human stomach and has a prominent fundus that lacks parietal cells. A description of the macroscopic and microscopic anatomy is presented along with a recommended sectioning pattern for nonclinical toxicity studies and discussion of species differences. A thorough understanding of normal anatomy and species comparisons are critical to interpretation of potential toxicity findings and assessment of risk in humans.

Key Words: Cynomolgus • monkey • nonhuman primate • stomach • histology • anatomy

Abbreviations: AB, alcian blue • AB-PAS, alcian blue-periodic acid Schiff • BCIP, 5-Bromo-4-chloro-3-indolyl phosphate • DAB, 3’3-diaminobenzidine • H&E, hematoxylin and eosin • NBT, nitroblue tetrazolium • PAS, periodic acid Schiff • IHC, immunohistochemistry


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