Human Clinical Relevance of the Porcine Model of Pseudoallergic Infusion Reactions.

ABSTRACT: Pigs provide a highly sensitive animal model for pseudoallergic infusion reactions, which are mild-to-severe hypersensitivity reactions (HSRs) that arise following intravenous administration of certain nanoparticulate drugs (nanomedicines) and other macromolecular structures. This model has been used in research for three decades and was also proposed by regulatory bodies for preclinical assessment of the risk of HSRs in the clinical stages of nano-drug development. However, there are views challenging the human relevance of the model and its utility in preclinical safety evaluation of nanomedicines. The argument challenging the model refers to the "global response" of pulmonary intravascular macrophages (PIM cells) in the lung of pigs, preventing the distinction of reactogenic from non-re

SUBMITTER: Szebeni J 

PROVIDER: S-EPMC7235862 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature