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Volume 6, Issue 6(Suppl)
J Clin Toxicol 2016
ISSN: 2161-0495, JCT an open access journal
Page 120
Notes:
Euro Toxicology 2016
October 24-26, 2016
conferenceseries
.com
Toxicology & Applied Pharmacology
October 24-26, 2016 Rome, Italy
7
th
Euro-Global Summit on
The utility of the minipig as an animal model in regulatory toxicology
Gerd Bode
University of Gottingen, Germany
G
ratitude is within the ethical tradition of Japanese towards experimental animals, because these provide valuable data
for efficacy and safety of pharmaceutical compounds before first administration to humans. Researchers must therefore
develop strict responsibilities to use these models under strict adherence to the 3Rs (Refine, Reduce, Replace). Models
should be relevant; and a relevant model is an animal which expresses receptors/epitopes like humans, reveals comparable
pharmacodynamic effects and resembles humans in regard to kinetic parameters like metabolism, exposure levels, protein
binding and bioavailability. For primary or secondary pharmacodynamics, next to traditional species, also transgenic or disease
models are being used, but for non-clinical safety studies predominantly traditional rodents or non-rodents are tested. The
undesirable adverse reactions are often so subtle, that for optimal assessments excellent knowledge of specific or spontaneous
reactions is needed.Themodelmust easily be available, costs acceptable andnopaucity of historical data representing anobstacle.
There will be a continuation of using rats and mice for toxicity evaluations, but for non-rodents a growing refusal is felt
in using dogs and monkeys. This paper deals with the utility of the minipigs as an animal model in regulatory toxicology.
The advantages or disadvantages will be illustrated. The Gottingen minipig is a genetically managed model unlike the
dog and monkey toxicology models. The basis of the small size of the Gottingen minipig does not involve defective
genes. Commercial interests in the pig as an agricultural production species have driven the area of pig genomics.
There is no equivalent economic driver for progress in the dog or the non-human primate. The Gottingen minipig
is well positioned for the performance of toxicogenomics studies. The close sequence homology between pigs and
humans suggest that minipigs could be useful for the testing small molecules but also for biotechnology products.
The minipig is the only non-rodent model where transgenic animals can be readily generated, and reproductive technologies
are well developed in the pig. The biology of the minipig is comparable; practically all study types can be performed in the
minipig. For reproductive toxicology studies the minipig offers numerous advantages although the lack of placental transfer of
macromolecules may limit the role of the minipig in reproductive testing of biotechnology products. For safety pharmacology
studies the minipig is an advantageous model, particularly as regards the cardiovascular system. The immune system of the
pig is better characterized than that of the dog and as an omnivore the GI-tract reveals similar characteristics. Overall, the
mini-pig should be carefully considered as an alternative to dogs and monkeys; but of course, more comparative data is needed
for a rigorous assessment of the usefulness and the predictivity of this species for human drug-induced desired and adverse
reactions.
gerd-bode@t-online.deGerd Bode, J Clin Toxicol 2016, 6:6(Suppl)
http://dx.doi.org/10.4172/2161-0495.C1.021