Industry Survey of Approaches to Examination and Terminology of Spontaneous Changes in the Heart of Young Rats

Autor: Beverly E. Maleeff, Patrizia Cristofori, Rick R. Adler, Charlotte M. Keenan, Angela Hughes-Earle, Jan Klapwijk, Heath C. Thomas
Rok vydání: 2010
Předmět:
Zdroj: Toxicologic Pathology. 38:995-998
ISSN: 1533-1601
0192-6233
Popis: Toxicologic pathologists are tasked with morphologic evaluation of tissues in animal toxicity studies to ascertain drug or chemical-related effects. These assessments are based on knowledge of the species and spectrum of morphologic changes that occur in the untreated control population. Within the rat heart, a number of morphologic changes have been observed as spontaneous events in control populations, one of the most common being myocardial degeneration or cardiomyopathy (Greaves 2000; King and Russell 2006; Kemi et al. 2000). Experience suggests this change can be observed with a highly variable incidence in very young rats and increases in severity with age; however, many classic literature descriptions identify this as a condition of aging rats. To gain better understanding of the industry’s approach to sampling the heart and terminology in common use in young rats, an informal survey was conducted in 2009 that focused on rat studies of 7 days’ to 28 days’ duration. The survey was sent to 89 individuals who represent the pharmaceutical (53), contract research organization (CRO) and consultant (35), or chemical industries (1). Responses were received from 36 contacts, for a 40.5% return rate. Respondents were asked if survey results could be published; all but one agreed. Sectors represented in the reported data include 20 pharmaceutical (13 North America, 5 Europe, 2 Japan), 9 CRO (6 Europe, 3 North America), 4 consultants (2 Europe, 2 North America), 1 chemical company (Japan), and 1 anonymous (unknown affiliation). A graphical summary of selected survey questions is presented in Figure 1A-J. The following general trends in short-term studies (less than 28 days) were noted
Databáze: OpenAIRE