Pre-clinical studies

Pre-clinical studies are the first step to the process of approval and output of new medicinal products to the Russian pharmaceutical market. These studies allow to estimate both efficiency and safety of medicinal products administration. The further procedure of State Registration of medicinal products depends directly on the volume and the quality of pre-clinical studies performed for these medicinal products as it makes possible to guarantee their safety when performing clinical studies. 

Pre-clinical studies can be divided into two main groups:

1. Pharmacology studies of:                                                                                      

• therapeutic efficiency;                                                                                            
• influence on the main anatomic and physiologic body systems;          
• possible side effects connected with the pharmacologic activity of the medicinal product being studied;

2. Toxicity studies:

• acute toxicity single- dose study;
• chronic toxicity study with repeated administration of the medicinal product during one year or more;
• specific activity detection (oncogenicity, mutagenicity, embryotoxity, including teratogenic activity, allergenic properties, drug dependence).

PharmRegS is a full-service partner for complete pre-clinical development needs of both original and generic medicinal products. 

Our services include:

• Sites selection;
• Development of pre-clinical studies design;
• Evaluation of the extent of pre-clinical studies depending on the task assigned (e.g. development of pre-clinical studies design for the original or generic medicinal product, identification of new properties of the already approved medicinal product etc.);
• Organizing the experimental part of pre-clinical studies;
• Working out the report on pre-clinical studies in accordance with the requirements of the Russian regulatory bodies.

When registering generics in RF, it is required to perform the study of  systemic toxicity (acute, subchronic and chronic toxicity). In some cases it is necessary to perform additional pharmacokinetic studies (absorption, volume of distribution, metabolic course and excretion of medicinal product being studied).

When registering original medicinal products in RF, the following additional studies are to be performed:

• Cumulative effect;
• Topical-product-induced irritation;
• Specific toxicity (allergenic capacity, immunotoxicity, embryotoxity, teratogenicity, influence on the reproductive function);
• Specific pharmacological activity;
• Comparative antimicrobial activity of antibiotics (in vitro).

After considering the results of pre-clinical studies, a corresponding resolution of advisability of clinical studies performance is made.