Nonclinical Toxicology Testing Strategies and Applicable International Regulatory Guidelines for Using Nonhuman Primates in the Development of Biotherapeutics

摘要: Abstract This chapter describes the strategic and regulatory considerations when using nonhuman primates (NHPs) in nonclinical development of biotherapeutics (i.e., biologics). The foundation program is selection pharmacologically-relevant species, which based on a weight-of-evidence approach silico, vitro, vivo data. NHP, particular cynomolgus monkey, frequently selected as relevant species for programs because specificity these molecules (in contrast to small molecules, usually have broader range species). There are several international guidelines available help guide development, most notable being ICH S6(R1). These guidelines, combined with an understanding pharmacology target mechanism action drug candidate, strategy. focuses important aspects toxicity NHPs assessment biotherapeutics, such selection, study design, consideration specialized end points/studies safety pharmacology, developmental reproductive toxicity, carcinogenicity. In addition, topics immunogenicity hypersensitivity, described.