Single-dose toxicity study biopharmaceuticals

Immunotoxicity testing guidelines exist for small molecules where the toxicology is largely unpredictable and rodent species are typically used [4]. Despite the lack of a specific guidance on immunotoxicity evaluation until now, most biopharmaceuticals have assessed the immunotoxic potential of the biophar-maceutical as a part of general single- and/or repeat-dose toxicity studies [5,23]. 

---