Very often, the development of New Chemical Entities (NCE) must be stopped following abnormal toxicity, safety margin issue, mutagenicity, cardiovascular or neurological adverse effects. To detect these deleterious events as early as possible, ERBC conducts exploratory safety programs combining in vitro and in vivo toxicity assays (in rodent and non-rodent species) and predictive biomarkers.
To optimize the costs and timing, the administrative work is minimized as much as possible, the experimental procedures are described in standard study plans, and all details specific to each study will be described in an information study sheet.
Low costs are also achieved through reduction of animal number while sensitivity is maintained by using low variability model, appropriate statistical designs (2 biostatisticians in the team) and application of very powerful approach such as the probabilistic method. In the same way, a summary report including the results of each test in each model, the interpretation of results and a description of the experimental methods are issued just after the end of the ultimate experimental phase (less than 2 weeks after the last experimentation).