Drug development process is very long and laborious. It includes a lot of trials in a preclinical research center which are indispensable for the emergence of the drug on the market. Preclinical studies of drugs are the basis for further clinical trials.
This stage includes determination of:
- general toxicity;
- reproductive toxicity;
Preclinical studies in animals are carried out to minimize adverse reactions while testing in humans. These studies give us an opportunity to determine the indications for drug use, contraindications and adverse effects, to understand the scope of further clinical trials and possibility of their conduction.
Features of preclinical studies of drugs
The study of original drugs includes determination of general and specific toxicity, pharmacodynamics and pharmacokinetics. While conducting preclinical studies of drugs-generics, we confine ourselves to investigate their general toxicity and pharmacokinetics (in several cases additional studies may be needed).
In addition, in the stage of preclinical studies we may determine the dose-dependency of drug effects. Preclinical studies in animals give us an opportunity to find out the highest possible safe dose and the feasibility of its increase. Preclinical studies are necessarily accompanied by a detailed report about all important aspects of the research work including information about the animals, ways of drug administration, tested concentrations, and data analysis of study results. In the stage of preclinical studies supposed doses are also explained for further clinical trials.
- Study on a safety of drugs and chemicals
- Pharmacokinetics assessment of drugs and substances
- Study of drugs and chemicals affecting central nervous system and physical efficiency
- Assessing an efficiency of drugs and dietary supplements in the models of hypoxia and ischemia
- Study of pharmacological agents affecting cardiovascular system
- Models for studying anti-inflammatory action
- Models for studying the action of pharmaceuticals in pathology of the upper respiratory tract and bronchopulmonary apparatus
- Models for studying gastro- and enteroprotective action of pharmaceuticals
- Models for studying the pharmaceuticals affecting metabolic disorders
- Models for studying hypoglycemic and anti-diabetic pharmaceuticals
- Study on the hepatic and choleretic effects of pharmaceuticals
- Study of pharmaceuticals used in treating pathologies of urogenital system
- Study of hormonal pharmaceuticals for systemic use
- Study of pharmaceuticals used in treating dermal diseases
- Study of antibacterial activity of pharmaceuticals for systemic use
- Study on antitumor activity of drugs and chemicals with immunomodulatory properties
- Study of pharmaceuticals affecting musculoskeletal system, in vivo and in vitro
- Study of pharmaceuticals affecting hematopoiesis and the blood system
- Study of pharmaceuticals used in therapy of senses
- Study of pharmaceuticals having anti-allergic properties
- Study of pharmaceuticals having antioxidant and antiradical properties
- Study on the mechanisms of action of pharmaceuticals