Rat ovariectomy (OVX) model is the most commonly used and extensively studied animal model of postmenopausal osteoporosis. Regulatory guidelines of FDA and EMEA state that the preclinical efficacy of any new therapy for postmenopausal osteoporosis should be tested with the rat OVX model in order to get regulatory approval.
Pharmatest can test your new drug candidates in the rat OVX model according to the regulatory guidelines of FDA and EMEA. When necessary a preliminary 2-week study can be first performed for identifying the best out of several potential compounds and finding its optimal doses. Efficacy of the best compound can then be confirmed with a more extensive 8-week study before entering a 12-month regulatory study. Preclinical efficacy studies can also be performed with intact female rats, or intact female mice that require lower amount of test compound.
Pharmatest has specific standard study setups for testing compounds with anti-catabolic and anabolic bone effects. We also provide tailored study setups for testing biosimilars and functional foods that have less extensive regulatory requirements. A list of bone analyses that we offer in our animal models can be found in our list of bone analysis services.