Identifying nonhazardous substances in pharmaceutical manufacturing and setting default health‐based exposure limits (HBELs)

Contract Development and Manufacturing Organizations (CDMOs) that manufacture large, diverse portfolio of chemical and pharmaceutical substances require pragmatic risk‐based decisions with respect to the safe carry‐over between different chemical entities, as well as for worker protection. Additiona...

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Veröffentlicht in:	Journal of applied toxicology 2022-09, Vol.42 (9), p.1443-1457
Hauptverfasser:	Wiesner, Lisa, Araya, Selene, Lovsin Barle, Ester
Format:	Artikel
Sprache:	eng
Schlagworte:	Additives CDMO Decision trees Exposure limits Food additives GRAS health‐based exposure limits Ingredients Intravenous administration Manufacturing nonhazardous substances Occupational exposure Occupational Exposure - adverse effects Occupational Exposure - analysis Occupational health OEL patient safety PDE Pharmaceutical Preparations Pharmaceuticals Risk Assessment Subgroups
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