Good laboratory practice animal dosing

Much of what is done (and how it is done) in repeat-dose studies is a response to a number of regulations. Three of these have very broad impact. These are the Good Laboratory Practices requirements, Animal Welfare Act requirements, and regulatory requirements that actually govern study design. 

In considering the adequacy of specific investigations as a basis to identify hazard in risk assessment, several features of study design are considered including the purity of the compound administered, the size of the study (i.e., numbers of exposed and control animals), whether the study was performed under Good Laboratory Practice standards, the relevance of the route of exposure to that of humans, duration of exposure, the number and suitability of the dose levels administered, the extent of examination of various toxicological endpoints, and the statistical analysis of the data (HC 1994 Meek et al. 1994). Criteria for the technical adequacy of animal carcinogenicity studies have been published (e.g., Chhabra et al. 1990 NTP 1984 OSTP 1986). 

---