Preclinical Trials of Medicinal Products

  In order to successfully complete registration of and obtain Marketing Authorization for a pharmaceutical product, it is required to provide sufficient scientifically justified data on safety and efficacy of a medicinal product based on the series of preclinical and clinical trials conducted in accordance with existing laws and regulations, as well as reference documents. Preclinical trials of medicinal products and preclinical testing of medical devices is an important step towards obtaining clinical trial and further marketing authorizations.

Ordinarily, final goal of clinical trials would be profiling compound’s mode of action through studying chemical and biochemical interaction of its molecules with the molecules of a potential or identified target. These studies are aimed at confirmation of the fact if molecular interaction and what concentrations of thereof, leads to any reaction. Results of such studies allows for preliminary calculation of therapeutic index of the product being studied (effective dose, toxic dose, lethal dose). Animal testing is another important stage of preclinical trials. This type of studies provides the most accurate understanding of therapeutic index, allows for preliminary safety profile, defines pharmacokinetic and pharmacodynamic profile, reveals potential adverse effects.

Megainpharm GmbH is experienced in preclinical trials management within the territory of Russia and the European Union. We cooperate with numerous scientific research centers in order to design the most effective preclinical trials plan complying with all existing laws, regulations and reference documents. Successful completion of preclinical trials results in clinical trials authorization for further studies of medicinal product safety and efficacy.

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