title: Regulatory acceptability of the minipig in the development of pharmaceuticals, chemicals and other products.
abstract: As part of the RETHINK European FP6 Project an overview of the acceptability and usefulness of minipigs has been carried out in the regulatory arenas of human and veterinary pharmaceuticals, food additives, cosmetics, biocides and agrochemicals, chemicals and medical devices. The safety of new pharmaceuticals for human use should be tested in non-rodents, but the regulatory world is not too prescriptive regarding the choice of species. The choice is most often dogs through long tradition. When dogs are not appropriate, in many cases non-human primates are chosen as an alternative. From information in the public domain as well as literature from the EMA and FDA, it is clear that minipigs have already been identified as suitable to take the role of non-rodent species in toxicity testing of pharmaceutical products. In the field of foodstuffs, the pig is used more extensively because of the apparent similarity in the omnivorous food pattern and digestive tract between humans and pigs. The extensive use of pigs in this field provides historical data. In the field of medical devices the ISO Guidelines indicate that the pig is regarded as a suitable animal model because of its haematological and cardiovascular similarities to man. The pig is also mentioned as suitable for testing local effects after implantation. Political and societal support for using nonhuman primates is decreasing, and it is an appropriate time to consider the role of the minipig. We have reviewed the costs of testing in minipigs, and these are not significantly higher than the costs for a study in dogs. Economical reasons should therefore not be used to argue against the use of minipigs instead of dogs or monkeys. For most purposes, minipigs may be considered an acceptable choice as non-rodent species, provided adequate justification for this choice is made.
authors.affiliation: Section on Safety of Medicines and Teratology, Centre for Biological Medicines and Medical Technology, National Institute for Public Health and the Environment, Bilthoven, The Netherlands. Jan-Willem.van.Laan@rivm.nl
authors.forename: Jan Willem
authors.initials: JW
authors.lastname: van der Laan
authors.forename: John
authors.initials: J
authors.lastname: Brightwell
authors.forename: Peter
authors.initials: P
authors.lastname: McAnulty
authors.forename: Joszef
authors.initials: J
authors.lastname: Ratky
authors.forename: Claudia
authors.initials: C
authors.lastname: Stark
mesh_terms: D023401:Animal Use Alternatives; D000818:Animals; D000830:Animals, Laboratory / Q000502:physiology; D018795:Device Approval / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D005260:Female; D059022:Food Safety; D033161:Government Regulation; D006801:Humans; D008297:Male; D023421:Models, Animal; D013552:Swine; D013556:Swine, Miniature / Q000502:physiology; D018675:Toxicity Tests / Q000191:economics / Q000592:standards* / Q000662:veterinary; D014481:United States; D014486:United States Food and Drug Administration; D015262:Xenobiotics / Q000633:toxicity*
chemical_list: D015262:Xenobiotics