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ASTM E3219 PDF
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Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
| Published by | Publication Date | Number of Pages |
| ASTM | 02/01/2020 | 30 |
ASTM E3219 – Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
1.1 This guide describes the scientific procedures underlying the integrative interpretation of all data concerning an active pharmaceutical ingredient (API) taking into account study adequacy, relevance, reliability, validity, and compound-specific characteristics (for example, potency, toxicological profile, and pharmacokinetics) leading to a numerical value for the API, which is used further in the quality risk management (ICH Q9) of cross contamination during the manufacture of different products in the same manufacturing facilities.
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