Abstract
In the context of drug development programs, studies of the nonhuman primate (NHP) often play a prominent role in skeletal assessment. Many therapeutic agents with a mechanism of action involving the skeleton use the monkey for bone efficacy and safety assessments because of the similarities between the skeletons of NHPs and humans. This chapter provides scientists engaged in drug development programs an understanding of the unique role that the NHP can play in characterizing skeletal effects. Basic principles of skeletal structure and function are reviewed, with an emphasis on comparisons of the NHP skeleton to that of humans and rodents. A comprehensive set of methodologies to assess the NHP skeleton are available and are summarized in this chapter. These methods include bone densitometry, biomechanical testing, biomarkers of bone formation and resorption, histology, and histomorphometry. Practical aspects for implementing these measures in routine toxicity studies are briefly described in this chapter.
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