The launch of pharmaceutical and parapharmaceutical products onto the Russian pharmaceutical market implies a number of preclinical studies of drugs and substances. The results of original preclinical studies of the drug are mandatory for state registration of medicines. For the purpose of registration of medicinal products, we offer the required minimum of preclinical studies based on analysis of the product to be registered (generic drug, original drug for the Russian market, the pharmacotherapeutic group, etc.).
The purpose of preclinical studies of drugs is to evaluate and prove scientifically the efficacy and safety of medicines.
We collaborate with leading experimental laboratories of the country which have powerful and high-tech resources and quality control services enabling them to conduct preclinical studies in compliance with international GLP guidelines and the requirements of Russian legislation.
RDG Services:
- Preclinical toxicity studies:
- acute toxicity study,
- subacute and chronic toxicity study,
- assessment of the overall condition of the animals,
- total and complete blood count,
- evaluation of the functional state of liver and kidneys,
- electrocardiographic examination
- cumulative effects study,
- study of cognitive functions in experimental animals,
- histopathological examination of the internal organs,
- local tolerance studies ,
- allergenicity, immunotoxicity, embryotoxicity and teratogenicity studies,
- mutagenicity and carcinogenicity studies of drugs
- comparative microbiological evaluation of antibacterial drugs
- Investigation and confirmation of the pharmacological properties of drugs
- Search for new pharmaceutical substances using the technology of combinatorial chemistry and high-performance screening
- Development of new drug substances and combinations
- Search for new therapeutic indications for the use of medicines
- Research of molecular and cellular mechanisms of action of drug substances in biological targets
- Study of safety of biotechnological medicines
- All types of pathological and histological studies
For the purpose of registration of medicinal products, we offer the required minimum of preclinical studies based on analysis of the product to be registered (generic drug, original drug for the Russian market, etc.).
Estimated costs for preclinical studies: from 750 000rubls (minimal scale for the registration of generic drug), may vary and depend on the scale of studies and their duration.