ARS organizes and conducts all types of preclinical studies of medications under GLP, international and local standards in Russia and abroad, including:
- general toxicity (acute, sub-acute, and chronic toxicity, and local irritating effect)
- specific toxicity (allergenicity, immunotoxicity, mutagenicity, carcinogenicity, reproductive toxicity, embryotoxicity)
- specific pharmacological activity
For years ARS has been working with a number of leading preclinical research units; tens of different products have been tested and applied for registration in Russia.
ARS is ready to recommend you the best lab for your preclinical program, consult with the leading experts to determine the optimal scope of studies; develop a preclinical protocol; conduct statistical analysis and prepare a preclinical report meeting the Russian regulatory requirements.
The studies’ results coming either from Russian preclinical labs or foreign ones are accepted by the authorities; however, the scope of such studies depends on the type of a product, treatment duration, route of administration, indication, and other factors. Since 2016, in accordance with FZ-61, it is not compulsory to provide own preclinical research results for generics’ (incl. FDCs’) registration in Russia, if the terms of article 18 are complied.