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Introduction The non-clinical development program sufficiently follows the worldwide regulatory guidance and it was considered complete by the CHMP SA procedure EMEA H SA 466 I 2004 III ; . A sufficient number of in vitro tests showed the selectivity of ALI to renin. Since renin displays strong speciesdependent substrate specificity, the main in vivo experimental models used BP response to a human renin. They provided insight into the PD properties demonstrating antihypertensive effects of ALI, with range of effective doses between 0.3 mg kg to 50 mg kg, depending on the models and on the administration route. The toxicity studies employed rats and marmosets, species used as pharmacological models, which displayed metabolic profiles similar to humans. Safety margin calculations have been performed considering the human exposure after the highest expected clinical dose of 300 mg. All non-clinical studies in the toxicology program were performed with oral route, except one study in rats when ALI was administered intravenously and local tolerance studies. In the PD program, oral, iintravenous and osmotic minipump administration have been used. ALI showed generally a non-linear pharmacokinetics PK ; with low bioavailability and overproportional exposure after oral dosing in all species. Many of the administration distribution metabolism elimination ADME ; studies were conducted using a 3H and 14C labelled drug substances. Pharmacology Primary pharmacodynamics In vitro studies with ALI showed its potency in inhibition of human recombinant renin and marmoset renin. ALI is less potent in various non-primate species. Moreover, ALI was inactive or only weakly active against human aspartic proteinases and HIV-1 proteinase. In vivo ALI was tested in marmosets, mice, and two stains of transgenic rats: 1 ; double transgenic rats dTGR ; expressing the human genes for renin, and 2 ; transgenic rats TGR ; , that express mouse renin. Spontaneously hypertensive rats SHR ; , in which ALI monotherapy evokes a weak antihypertensive response, were used to test the antihypertensive effect of combining this RI with other inhibitors of the RAS. The in vivo models for and triphasil.
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