Format

Send to

Choose Destination
Reprod Toxicol. 2016 Sep;64:105-15. doi: 10.1016/j.reprotox.2016.04.019. Epub 2016 Apr 22.

"All pigs are equal" Does the background data from juvenile Göttingen minipigs support this?

Author information

1
Preclinical development and safety, Janssen Research & Development, A Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium. Electronic address: bfeyen@its.jnj.com.
2
Wil Research, a Charles River Company, 329 impasse du Domaine Rozier, 69210 Saint-Germain-Nuelles, France.
3
Preclinical development and safety, Janssen Research & Development, A Division of Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

Abstract

For pediatric indications requiring juvenile toxicity testing, the rat is the preferred species. However, for some drugs it might not be an appropriate model or regulatory agencies may also request a non-rodent species. Due to the relatively recent use of Göttingen minipigs, little background data are available. This shortage of historical data can raise concerns with respect to interpretation, thus potentially discouraging investigators. This article presents background data from 82 piglets collected at different ages. The data described show the normal variations and changes which are important in the interpretations of these studies. Age-related changes were observed for several cardiac and clinical pathology parameters and in the haematopoietic tissues. Therefore, all pigs were not considered equal. It can be concluded that these data can be used as guidance, to support the concurrent study control data but cannot completely replace them.

KEYWORDS:

Background data; Clinical pathology; Growth parameters; Histopathology; Juvenile; Minipig

PMID:
27112527
DOI:
10.1016/j.reprotox.2016.04.019
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center