Toxicology

Compliance of the three main conditions (so-called 3G) is necessary for drug and vaccine development and production in the developed countries:

Now Russia succeeded in the field of GMP principles adoption, there are Russian clinics conducting clinical trials according to GCP principles, but there are no organizations conducting preclinical trials according GLP system so far.

All toxicological studies in Bonasana will be conducted in strict conformity with the developed standard harmonized with international GLP standards. Bonasana’s personal will work strictly according to the standard operational procedures. All employees will have specialized training for realization of toxicological research. Experienced foreign experts-toxicologists will take up key positions in Bonasana. Training on fulfillment of trials in conformity with GLP under guidance of foreign experts will be obligatory for Russian staff.

Accreditation of the Center of Preclinical Trials in Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) will be conducted.

Information received from long-term research will allow to lay the basis for creation of Russian nanomaterials toxicological research standards harmonized with the international standards.