Preclinical study (PS) is a fundamental stage in the development and implementation of the medicinal product (MP) in clinical practice, allowing in timely manner to study pharmacological, toxic and pharmaceutical properties (FP) and to evaluate the efficacy and safety of pharmacological product, and make up a significant part of the registration dossier, which is formed for state registration of the MP. The results of preclinical study are submitted with the report of clinical research and project of Basic Prescribing Information to address the issue on the possibility of conducting clinical research.
Since the formation of the idea of a new medicinal product creation, the process of its development is inextricably linked with the conduct of preclinical screening studies. Such studies enable to estimate the efficacy of a substance or a combination thereof, and to choose the optimal composition of a future MP. After approval of the MP composition the preclinical studies of safety and efficacy are conducted.
Preclinical safety studies of MP are aimed at identifying of possible damaging effect of MP action and safety evaluation of its application. Such studies are nominally divided into two major blocks:
Study of systemic toxicity, which includes the evaluation of acute, subchronic and chronic toxicity. At this stage, toxic doses are detected, as well as the major organs and systems of the body exposed to the damaging action of pharmacological product.
Study of specific toxicity is directed at identifying the reproductive toxicity (embryotoxicity, teratogenicity, effects on the generative function), allergenicity, immunotoxicity, mutagenicity and carcinogenicity of pharmacological product.
Preclinical study of effectiveness is an evaluation of pharmacological activity of potential medicinal product for treatment of a disease, as well as the pharmacodynamic properties of medicinal products. This type of research is conducted on models of diseases of laboratory animals and is the basis for the development of indications for use and design of future clinical trials.
For selection of doses and schemes of MP use the pharmacokinetic preclinical studies are performed including the study of absorbability, distribution, metabolism and excretion of medicinal products from the body. These preclinical studies are also an indispensable part of assessment of bioequivalence of generic MP.
Currently, research centers possess a significant arsenal of methods to assess toxicity and pharmacological activity of MP. Regardless of the amount of preclinical studies the obtaining of reproducible and reliable data is guaranteed by the principles of GLP and GCP.
Services of our company in conducting of preclinical studies include the following:
- Selection of the basis for preclinical studies;
- Preparation of technical specification for conducting a preclinical study. Matching the model and the volume of research with the experts of the research center;
- Development of a pre-clinical study protocol;
- Monitoring and ensuring of the research quality;
- Statistical processing of the research results obtained;
- Preparation of reports on the studies conducted.
Our company carries out work closely with test centers which enables to optimize and reduce the time and costs for pre-clinical studies. Detailed calculation of costs and timing of the study makes it clear and understandable for you.
Experience of high-quality data processing enables to avoid inconsistencies in the available records, as well as generate reasonable conclusions about the tests carried out.