This paper describes the procedures for establishing ADEs, OEBs and OELs at Merck.
ADE values, OELs, OEBs and recommendations for medical surveillance and/ or medical response established by ITAC represent formal Merck standards and expectations.
METHODS FOR ASSIGNING OEBS AND DERIVING ADE VALUES AND OELS
OEBs, which were previously termed performance-based exposure control limits (PB-ECLs), represent a control banding concept and classification system that utilizes a set of criteria applied to chemical compounds and biological materials to rate them according to their inherent hazardous properties and characterized them with respect to the severity of each (Naumann et al, 1996).
OEBs are typically established by GSE toxicologists early in the drug development process when a compound is approved for development.
The first two entered individual/university variables as a first step and OEBs or local norms as a second; the third entered individual/university/local norms as a first step and OEBs as a second step; the last entered individual/university/OEBs as a first step and local norms as a second step.
Table 2 indicates that for every category of predictor variables except OEBs, the [R.sup.2] statistics are highest for size of research budget.
Table 4 shows the results of five regression models that were computed using the 16 individual, OEB, and local norm variables.