Article ID Journal Published Year Pages File Type
5857105 Regulatory Toxicology and Pharmacology 2013 9 Pages PDF
Abstract
► ADEs used to establish cleaning validation limits for pharmaceutical products. ► ADEs are defined as acceptable daily exposures for patients. ► ADEs defined for any route and for lifetime exposure. ► Guidance for establishing ADEs necessary to ensure industry consistency.
Keywords
Related Topics
Life Sciences Environmental Science Health, Toxicology and Mutagenesis
Preview
Guidance on the establishment of acceptable daily exposure limits (ADE) to support Risk-Based Manufacture of Pharmaceutical Products
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