Disease area and mode of action as criteria to assign a default occupational exposure limit

Glogovac, Milica; Paulson, Caylee; Lambert, Amy J.; Winkler, Gian Christian; Barle, Ester Lovšin

doi:10.1016/j.yrtph.2021.104891

Cited by 4 publications

(1 citation statement)

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“…The value was derived from a permissible daily exposure level of 1.5 μg/day for mutagenic impurities (EMA, 2014). Recently, Glogovac and coworkers proposed that in the absence of any compound‐specific data, a default OEL of 10 μg/m 3 is a reasonably safe exposure limit for small‐molecule drug candidates, except for hormones and oncology drugs, where a default OEL of 1 μg/m 3 is used at their organization (Glogovac et al, 2021). A limit of either 1 μg/m 3 or 2 μg/m 3 (OEB 4) will follow the same exposure control strategy at the manufacturing location.…”

Section: Oel For Data‐poor Substancesmentioning

confidence: 99%

Approaches for setting occupational exposure limits in the pharmaceutical industry

Ahuja

Krishnappa

2021

J of Applied Toxicology

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The use of pharmaceutical drugs has provided a cure for many diseases. However, unintended exposure to drugs in the manufacturing workplace can cause significant health hazards to workers. It is important to protect the workforce from these deleterious effects by limiting exposure to an acceptable level, the occupational exposure limit (OEL). OEL is defined as airborne concentrations (expressed as a time‐weighted average for a conventional 8‐h workday and a 40‐h work week) of a substance to which nearly all workers may be repeatedly exposed (for a working lifetime) without adverse effects. Determination of OELs has become very challenging over time, requiring an overall assessment of the preclinical and clinical data of the drug being manufactured. Previously, to derive OEL values, toxicologists used animal no‐observed‐adverse‐effect level (NOAEL) data, which have been replaced with the overall assessment of animal and human data, placing a higher emphasis on human health‐based data. A major advantage of working with human pharmaceuticals is that sufficient clinical data are available for them in most cases. The present manuscript reviews the latest knowledge regarding the derivation of occupational exposure limits as health‐based exposure limits (HBELs) for pharmaceuticals. We have provided examples of OEL calculations for various drugs including levofloxacin (CAS No. 100986‐85‐4), dienogest (CAS no. 65928‐58‐7), and acetylsalicylic acid (ASA, CAS no. 50–78‐2) using human data. This report will benefit professionals in the OEL domain in understanding this highly important, growing, and challenging field.

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Section: Oel For Data‐poor Substancesmentioning

confidence: 99%