One of the sections of the Common Technical Document (CTD), which is necessary for the registration of a drug on the territory of Russia, is the module devoted to reports on preclinical trials.

According to Federal Law No. 61 preclinical trial of the drug (PCT) – biological, microbiological, immunological, toxicological, pharmacological, physical, chemical and others research of the drug by applying scientific assessment methods to obtain evidence of the safety, quality and efficacy of the drug.

In other words, PCT for drugs are tests, usually conducted in vitro and in vivo conditions on animals, before the beginning of clinical trials of drugs in humans.

The main objectives of PCT for drugs are:

1. Study of the pharmacological activity of the active substance;

Within the framework of this type of research the biochemical and physiological effects of the active substance on the body, microorganisms or parasites, as well as the mechanism of action and the relationship between concentration of the active substance and its effects;

2. Study of pharmacokinetic properties of the active substance and dosage form;

Pharmacokinetic study involves studying the mechanisms of absorption and distribution of the active substance, the start time and duration of pharmacological effects, chemical changes of pharmaceutical substances in the body and ways of excretion of its metabolites.

3. Study of toxicological properties of the active substance;

The study of so-called preclinical safety is devoted to the description of toxic effects in relation to target organs, dose-dependence.

It should be noted that approaches to preclinical study are different and depend on nature and properties of the drug, degree of innovation, stage of clinical development, conditions of application.

The protocol of the PCT for drugs consists of a plan and program. The signing of the protocol is the beginning of the PCT. At the end of the PCT, a final report is drawn up, which contains the following information:

1). Characteristics and justification of the test system (including animals) selected for preclinical trials.

2) Dosing regimen, multiplicity and way of introduction of the substance, drug

3) Description of statistical processing methods and brief overview of PCT results

4) PCT results

5) Evaluation of results and findings of PCT

The final report is signed by the head of the PCT. Changes, additions to the final report are signed by the head of the PCT and issued in the form of annexes.

References:

1. FZ-61 (ФЗ №61 «Об обращении лекарственных средств»)
2. Order of Minzdrav 199n (Приказ Минздрава России от 01.04.2016 N 199н «Об утверждении Правил надлежащей лабораторной практики»)
3. Васильев А. Н. Качественные доклинические исследования – необходимый этап разработки и внедрения в клиническую практику новых лекарственных препаратов // Антибиотики и химиотерапия. №1-2.

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©Beawire – March 2019 with updates from May 2019.