title: Assessment of pulmonary function and serum substance levels in newborn and juvenile rats.
abstract: In the context of pharmaceutical development today, studies for pediatric drug approval are requested more and more often by the regulatory authorities. The developing lung represents a potential target in juvenile toxicity studies. Due to physiological differences in prenatal and postnatal development between humans and standard animal models, experimental methods have to be modified to assess pulmonary function, and basic data on respiratory parameters need to be provided. Daily nose-only inhalation exposure from postnatal days 4 to 21 using a model substance (verapamil HCl) and plethysmographic measurements between postnatal days 2 and 50 were performed noninvasively in conscious juvenile Wistar (WU) rats. The methods proved to be feasible and did not interfere with normal growth and development of the animals. Both techniques therefore permit new insights to support human neonatal risk assessment and therefore these animal models are suitable for regulatory studies.
authors.affiliation: Fraunhofer Institute for Toxicology and Experimental Medicine, Nikolai-Fuchs-Strasse 1, 30625 Hannover, Germany. geertje.lewin@item.fraunhofer.de
authors.forename: Geertje
authors.initials: G
authors.lastname: Lewin
authors.forename: Heinz-Gerd
authors.initials: HG
authors.lastname: Hoymann
authors.forename: Rainer
authors.initials: R
authors.lastname: Fuhst
authors.forename: Edith
authors.initials: E
authors.lastname: Berger-Preiss
authors.forename: Gerhard
authors.initials: G
authors.lastname: Pohlmann
authors.forename: Jochen
authors.initials: J
authors.lastname: Buschmann
mesh_terms: D000280:Administration, Inhalation; D000375:Aging / Q000187:drug effects; D000818:Animals; D000831:Animals, Newborn; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D008168:Lung / Q000187:drug effects*; D008297:Male; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000097:blood; D010993:Plethysmography, Whole Body; D051381:Rats; D017208:Rats, Wistar; D014700:Verapamil / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood
chemical_list: D004364:Pharmaceutical Preparations; D014700:Verapamil