… approaches to evaluating the safety of a biopharmaceutical must be considered. Alternative
… of preclinical safety assessments of species-specific biopharmaceuticals, although many …

… 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 …

… number of species-specific biopharmaceuticals in development, it becomes even more
important to demonstrate that the knockout mice are a viable alternative to testing in NHP and are …

… many biopharmaceuticals are species-specific, alternate … For molecules that show
species-specific cross-reactivity … to conduct reproductive and developmental toxicity studies in rats …

… 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 …

… nonclinical testing of species-specific proteins in animal studies … produced in substrates
other than mammalian cells (eg … of biopharmaceuticals having their own inherent safety testing …

… The S5A guidance also states that other strategies or combinations of studies and study …
-life of the biopharmaceutical. The non–species-specific biopharmaceutics include recombinant …

… addressed how developmental studies should be conducted … stated that the actual testing
strategy should be determined … on toxicity, pharmacodynamics, kinetics, and similarity to other …