The importance of preclinical studies for the drug safety assessment and the pharmacovigilance system

Authors

DOI:

https://doi.org/10.24959/nphj.26.216

Keywords:

medicinal products; non-clinical studies of medicinal products; medicinal product safety assessment; risk minimization; pharmacovigilance; pharmacovigilance system; geriatric patients; pediatric patients.

Abstract

Aim. To analyze the essence, types and methodological approaches of preclinical studies, as well as their role in forming the drug safety profile and supporting the pharmacovigilance system.

Materials and methods. Regulatory documents, international standards and scientific publications concerning preclinical studies and their significance in the drug safety assessment and the functioning of the pharmacovigilance system were reviewed.

Results. Preclinical studies are essential for assessing the safety of medicinal products as they provide data on the mechanisms of action, effects on vital organs and the toxicological profile. Their results are extrapolated to humans taking into account interspecific differences. Compliance with Good Laboratory Practice principles in safety and toxicity studies guarantees the reliability and reproducibility of the data obtained. Within the pharmacovigilance system, preclinical studies play an important role as they allow us to identify new risks, clarify the mechanisms underlying suspected adverse reactions, confirm or refute safety signals, and evaluate causal relationships when clinical data are limited. They also help determine potential class effects, target organs of toxicity and supplement information on risks that cannot be studied in humans for ethical reasons. Thus, preclinical models remain an important tool for forming the safety profile and supporting regulatory decision-making.

Conclusions. Preclinical studies are a key component in assessing the safety of medicinal products and the functioning of the pharmacovigilance system. They form the basis for predicting risks, support the interpretation of post-marketing safety signals and are used in regulatory decision-making. Further technological development will strengthen their role while gradually expanding the potential of alternative models aimed at reducing the use of animals in research.

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