Comparison of Permitted Daily Exposure (PDE) Values for Active Pharmaceutical Ingredients (apis) - Evidence of Robust Approach

Claudia Sehner, Tanja Bernier, Kamila Blum,Nicole Clemann,Milica Glogovac,William A. Hawkins, Martin Kohan, Fenneke Linker, Ester Lovsin-Barle, Osahon Osadolor,Thomas Pfister, Elisa Schulze,Markus Schwind,Gregor Tuschl,Lisa Wiesner

REGULATORY TOXICOLOGY AND PHARMACOLOGY（2024）

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关键词

Health based exposure limit (HBEL),Permitted daily exposure (PDE),Acceptable daily exposure (ADE),Cleaning validation,Active pharmaceutical ingredient (API),Cross-contamination,Harmonisation,Multipurpose facility,Pharmaceutical manufacturing,Hazard assessment

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