The Board of the Eurasian Economic Commission approved the guidelines for study of toxicokinetics and assessment of systemic exposure in toxicological studies of drugs. Press service of the Eurasian Economic Commission (EEC) reports.
The document will come into force in July 2021. The guidelines contain instructions for planning, conducting and evaluating the toxicokinetic parameters of drugs. The document includes guidelines for assessing the concentrations of an active substance created in the body, establishing relationship between this concentration and the possible toxic effect on the body as a whole.
«The document will allow eliminating the differences in the volume of requirements imposed by the authorized bodies of the states of the Eurasian Economic Union when assessing the safety of a medicine and the potential adverse reactions caused by it in humans. It also excludes duplication in different EAEU states of toxicological studies by manufacturers of new drugs or registered drugs when new adverse reactions to them are detected,» the EEC stressed.
