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Vol. 16, Art. 42 (pp. 443-455)    |    2015       

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The procedure for preclinical, clinical trials and marketing authorization of new medicines administrated at extremal chemical situations

Petrov A.N., Bonitenko E.Yu., Zaytseva M.A., Ivanov M.B., Barinov V.A., Pikalova L.V., Potapenko E.G., Kashina T.V., Zatsepin E.P.

«Institute of Toxicology» of Federal Medico-Biological Agency

Brief summary

The development and introduction of effective medical protection (antidotes, pathogenetic and symptomatic medical products is one of the important elements of medical technologies of preventive actions and treatment at poisonings. The application of the medical products in extreme situations due to highly toxic chemicals has essential features, main of which is administration only under vital indications and during the limited time interval (more often one dose introduction). So for these products the toxicological testing on animals plays a key role at preclinical trials. Because of practical impossibility of carrying out of 3-rd phase of clinical trials, those clinical trials should be reduced to an estimation of their safety and pharmacokinetics on healthy volunteers. The suggested procedure for preclinical, clinical trials and marketing authorization of new medicines administrated at extreme situations due to highly toxic chemical substances impaction will allow in optimum terms and is economically justified to provide their application as medical protection of the population economically in optimal period.


Key words

non-clinical study, clinical study, drug, toxicant, marketing authorization.

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