EFFICACY STUDIES

Efficacy studies are therapeutic studies conducted with a validated cell culture or animal model representing a human disorder. At Biotest Facility we have experience with efficacy models covering a range of human diseases, and just as important, the expertise needed for setting up customised models. This requires experience, planning, and a sense of details. The disease models are induced by various methods: The transplantation of human cancer to an immunodeficient mouse is one such method, and surgery, chemical inducers, special diet, infectious agents, immunizations, and genetic modification are among other methods used to establish models for human diseases. Knowledge about formulation, administration route, dose and frequency, and a suited reference treatment if possible, are prerequisites for a successful efficacy study. Tell us about your specific need to prove a concept of a new therapy and let us suggest a suitable model.

EXAMPLES OF STUDIES

Examples of disease model established by immunizations are Myasthenia Gravis in rats by immunization with acetylcholine receptor (AChR), arthritis induced in mice immunization with collagen II, and Multiple Sclerosis induces by immunization with CNS tissue in mice.

Diseases induced by chemically inducers include examples such as the oxazolone-induced skin inflammation model of atopic dermatitis, 7,12-Dimethylbenz[a]anthracene-induced (DMBA) mammary cancer, or colitis induced by dextran sulfate sodium (DSS).

In the case of cancer, the models are more varied. This reflects the individual treatment and diverse disease etiology. The models are combinations of a vast number of donor tumor cells, of cells or tissue transplanted as xenografts, or of allografts to suited host animals. The hosts have different degrees of compromised immunity, and in some cases have been humanised with regard to the immune system. Let’s start at dialogue about which model you need for drug development program.

EFFICACY STUDIES AND COLONY MANAGEMENT

Genetical engineered models represent a large proportion of available rodent disease models. The time it takes to generate a new model was shortened considerably recently, however often accompanied with a necessity for considerable model characterization. Biotest Facility offers to maintain your colony of genetically engineered mice, and to conduct efficacy studies with the model.