… molecules or other modalities where two species toxicity testing is currently recommended.
… or where the biological activity of the biopharmaceutical is well understood). In addition, even …

… the biological activity of the biopharmaceutical is well understood). Toxicity studies in non-…
include species-specific (tissue) toxicity/tolerability for NCEs, and occasionally for biologics. …

… NHP should be used only if no other relevant animal species demonstrates an immune …
activity of the biopharmaceutical is well understood). Toxicity studies in nonrelevant species may …

… of biopharmaceuticals, it is important to perform the toxicology … For this program, toxicology
studies were conducted with a … least one toxicology species, species-specific surrogates are …

… species for the long-term toxicity studies whilst the other half progressed only 1 species, …
/or pharmacological effects, tolerability, species-specific off-target toxicity, exposure to drug, and …

… whether the finding could be species specific and therefore not of … not be appropriate for
biopharmaceuticals because of the … Similar to alternative preclinical testing strategies discussed …

… and design of combination toxicity studies should be based … molecular compound or other
biopharmaceutical could be … monkeys because the species-specific binding of rituximab for …

… to develop strategies for further toxicity testing of compounds … better predictability in testing
species-specific targets when compared … adjunct or alternative for biopharmaceutical testing. …

… alternatives to studies conducted in the NHP have been used to inform on EFD risk for
biopharmaceuticals … the use of species-specific surrogate molecules in alternative animal species …

… Furthermore, other safety guidelines for NCEs either state “… on-target toxicity may be evaluated
using an animal species-specific … for testing biopharmaceuticals, toxicity studies should, in …