Gadolinium Clearance in the First 5 Weeks After Repeated Intravenous Administration of Gadoteridol, Gadoterate Meglumine, and Gadobutrol to rats.

Background: Studies of gadolinium (Gd) clearance from animals in the first weeks after administration of gadolinium-based contrast agents (GBCAs) have previously looked at solitary timepoints only. However, this does not give information on differences between GBCAs and between organs in terms of Gd elimination kinetics.

Purpose: To compare Gd levels in rat cerebellum, cerebrum, skin, and blood at 1, 2, 3, and 5 weeks after repeated administration of macrocyclic GBCAs.

Specificities of the Skin Morphology in Juvenile Minipigs.

The Göttingen minipig is recognized by the scientific community and by health authorities as the animal model of choice to evaluate dermally applied drugs under development. Young adults of approximately 4 months of age are most generally chosen to participate in dermal pharmacology and toxicology studies, and recently, minipigs have been proved to be also suitable for juvenile studies. A complete anatomical cartography of the skin morphology of juvenile male and female minipigs from postnatal day 1 (PND1) to twelve weeks of age was performed measuring the thickness of skin layers for each anatomical location and time point.

Non-clinical assessment of safety and gadolinium deposition after cumulative administration of gadobenate dimeglumine (MultiHance) to neonatal and juvenile rats.

To determine the impact of single and cumulative doses of MultiHance on toxicity, pharmacokinetics, tissue gadolinium presence, behavior and neurological function in juvenile rats. Juvenile male and female rats received either physiological saline or MultiHance at 0.6, 1.

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

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.