Abstract
During pharmaceutical development, consideration must be given to medicines for treating children. Therefore it is normal to perform preclinical safety studies in juvenile animals as models of human children. In the case of drugs developed for dermal administration, this can give particular problems. Dermal drugs are normally developed using the minipig as a testing species due to the similarities between human and minipig skin. Dermal dosing of animals requires great care to avoid interference with the dosing sites by the animals. Use of single housing, collars and bandages is common. For minipigs, dosing of young animals from weaning at 4 weeks of age is straightforward, however for younger, preweaned animals there is a high risk of interference with the dosing site by the mother or siblings. This potentially prevents studies that would evaluate effects of drugs in animals of equivalent human age 0 to 2 years. Therefore we have conducted a study in pre-weaned minipigs to investigate the possibility of dermal dosing in such young animals. Minipigs were dosed dermally with a commercially available skin product starting from 7 to 14 days of age. The animals were bandaged whilst they were exposed to the treatment to prevent outside interference with the dose site. The animals were observed and the bandages inspected regularly to check whether the mother or the other young minipigs could interfere with the dose sites. This study allows us to conclude on the possibility of performing dermal studies on minipigs younger than 4 weeks of age.
