ABSTRACT
Studies-Inhalation Exposure . . . . . . . . . . 524 12.2.9 Nonclinical Pediatric Studies-Evaluations. . . . . . . . . 528 12.2.10 Nonclinical Pediatric Studies-Toxicokinetics . . . . . . 531
12.3 Discussion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 531 12.3.1 ICH Reproductive Toxicology Studies . . . . . . . . . . . . 531 12.3.2 Nonclinical Pediatric Studies-Effects on Pups . . . . . 533
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 534
For toxicity testing of pharmaceuticals to be administered clinically by inhalation, it is accepted that much of the testing will be performed using the clinical route, with nose-only or oronasal exposure systems being commonly used. These types of systems have several advantages over whole-body systems, including a lack of external deposition of the test article, resulting in avoidance of dermal absorption or oral ingestion via grooming and the utilization of less test article due to lower airflows and smaller chamber volumes.
