Biopharmaceuticals rodents/nonrodents

Four-week toxicology studies in rodent and nonrodent The four-week studies are designed for subchronic exposure of rodents and nonrodents to the test article. These studies also look at reversibility of any toxicity observed. Many times these are the pivotal studies used to support the first in human dosing. Toxicokinetic assessments are generally included in repeat-dose toxicity studies. When testing biopharmaceuticals, studies also include assessment and characterization of immune response (immunogenicity). 

Safety pharmacology studies in rodent and nonrodent These studies are designed to identify undesirable pharmacological effects in several systems primarily the cardiovascular, respiratory, and CNS systems. Other studies may be included based on the pharmacological activity of the test article. In many cases these studies are not required for biopharmaceuticals and/or may be included in the 4- and 13-week studies and 6- and 9-month studies. 

For both small molecules and biopharmaceuticals, regulatory guidelines state that nonclinical safety testing should be conducted in both a rodent and a nonrodent species (ICH M3R2, 2009 ICH S6R1, 2011). For some... 

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