The preclinical trial program is a document with design of the planned investigation.

A preclinical study plan is an essential document containing the information on aims, objectives, design, methods, statistical aspects and organization of the planned study. According to Order of August 23, 2010 No 708n, “A preclinical study should be performed according to the approved plan and should be accompanied by a protocol certifying the preclinical study plan procedures.

This is an investigation of pharmacokinetic properties of the product, its specific pharmacological activity, performed on animal models of diseases/syndromes. This type of studies helps evaluate the pharmacodynamic properties of the drug, further defining the scope and design of clinical studies, as well as clinical indications of the product.

The sensitizing properties must be evaluated after toxicity tests of all new pharmacological substances. Products containing protein impurities and high-molecular compounds are subject to particularly thorough evaluation. According to the Manual on Preclinical Trials of Medicinal Drugs (Mironov A.N., Bunatyan N.D., et al.), the product allergizing properties assessment may be included into the clinical trial protocol, draft instruction for its medicinal use, and in some cases may be used to define the subsequent steps with the product, along with its pharmacological and chemotherapeutic properties.

According to the Manual on Preclinical Trials of Medicinal Drugs (Mironov A.N., Bunatyan N.D., et al.), Immunotoxicity tests are required for the new, original pharmacological products, as well as established drugs with no immunotoxicity data available, indicated for long-term use at repeated doses; for use in pediatric practice, and for treatment of pregnant and nursing women; as preventive medicines and contraceptives; for over-the-counter use in general public. The following tests should be performed at the preclinical stage: genetic mutation induction test and in vivo chromosomic aberration test. The ability of the medicinal product to induce germinal mutations (a test to detect the risk of dominant lethal mutations in mice), needs to be tested before initiation of stage 3 clinical trials.

Carcinogenic Potential According to the Manual on Preclinical Trials of Medicinal Drugs (Mironov A.N., Bunatyan N.D., et al.), compulsory carcinogenicity tests are required for novel medicinal drugs for preventive care, contraception, cosmetic use, used in pediatric practice, for treatment of pregnant and nursing women; intended for life-time use or as long-term treatment with repeated doses; hormonal and hormone-lie substances; over-the-counter products for use in general public; biotechnological or genetically engineered products.

Reproduction toxicity studies of pharmaceutical substances are part of preclinical toxicology program. According to the Manual on Preclinical Trials of Medicinal Drugs (Mironov A.N., Bunatyan N.D., et al.), reproduction toxicity tests are required for all novel original pharmacological substances. Antineoplastic drugs intended only for treatment of cancer, and life-saving drugs are the only exceptions.

According to Federal Law dated April 12, 2010 No 61-FZ On Drug Circulation, general toxicity studies are an essential part of preclinical study program and are intended to test the drug safety. The end target of preclinical toxicology studies is to obtain data sufficient to determine the possibility and risk of conducting clinical trials of medicinal drugs.

Mutagenic Potential According to the Manual on Preclinical Trials of Medicinal Drugs (Mironov A.N., Bunatyan N.D., et al.), tests for mutagenicity must be performed on novel original pharmacological substances, obtained by chemical, biotechnological or genetically-engineered or other methods, including products obtained from natural raw materials and herbal products, as well as new fixed combinations of pharmacological substances, intended for large-scale clinical use. The following tests should be performed at the preclinical stage: genetic mutation induction test and in-vivo chromosomic aberration induction test. The ability of the medicinal product to induce germinal mutations (a test to detect the risk of dominant lethal mutations in mice), needs to be tested before initiation of stage 3 clinical trials.

Pharmacokinetic studies (body absorption, distribution and elimination kinetics) are an essential component of the preclinical study program. According to the Manual on Preclinical Trials of Medicinal Drugs (Mironov A.N., Bunatyan N.D., et al.) full pharmacokinetic studies must be performed for original active pharmaceutical substances, and for established substances, not previously used as pharmacological products.

Development of a new drug often requires a consultation by highly-reputed persons, so-called Key Opinion Leaders (KOLs), who are experts in a specific area of medicine and healthcare. These experts are highly influential for the medical practice. We offer information and analytical support of your projects engaging key opinion leaders.

We offer review and expert evaluation of studies and documentation, including monitoring of laboratory sites for compliance with GLP.

Scientific publications in peer-reviewed journals are an effective way to raise awareness about the study outcomes among healthcare professionals and practicing clinicians. Our team is experienced in the field of consultancy services and review of medical texts of all degrees of complexity. We guarantee a high level of expertise and quality of consultancy and information services involving writing and review of medical texts.

We localize the completed preclinical study reports in accordance with the requirements of the regulatory authorities of the Russian Federation.