Modern approaches to hygienic regulation of pharmaceutical substances in the air of the working area (literature review)

Drug independence of the Russian Federation requires the presence of full-cycle enterprises of strategically important medicines and, consequently, the safety of workers, which is impossible without modern approaches to the hygienic regulation of pharmaceutical substances in the air of the working area.

The purpose of the study was to identify prospective areas for updating the existing regulatory and methodological framework in the hygienic regulation of pharmaceutical substances in the air of the working area.

The article presents an analysis of domestic and foreign literature containing information on international and national approaches to the regulation of pharmaceutical substances in the air of the working area.

Modern approaches to hygienic regulation of pharmaceutical substances based on the use of NOAEL (no observed adverse effective level) and BMD (benchmark dose) as points of departure taking into account different safety factors, the use of pharmacokinetic modeling methods to extrapolate data from oral toxicity studies to inhalation, machine learning to predict the properties of chemicals, assessment of carcinogenic risk when rationing direct-acting genotoxicants, as well as on the establishment of standards for excipients of medicinal products and account for the biological activity of active substances that are analogues of endogenously synthesized substances.

The regulatory and methodological framework for hygienic regulation of pharmaceutical substances in the air of the working area requires updating, taking into account new approaches. The most promising is the use of NOAEL and BMD as reference points in the justification of safe exposure levels, and pharmacokinetic modeling.

Authors’ contribution: All co-authors have made an equal contribution to the research and preparation of the article for publication.

Conflict of interests. The authors declare no apparent and potential conflicts of interest in relation to the publication of this article.

Funding. The study is funded as part of the research project “Methodology development of the hygienic regulation of pharmaceutical substances in the air of the working area, the atmospheric air of populated areas and the water of water bodies” of the Rospotrebnadzor sector program “Hygiene”.

Received: November 22, 2025 / Accepted: November 25, 2025 / Published: January 15, 2026

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