| Předmět: |
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| Zdroj: |
Health & Medicine Week; 12/8/2023, p6583-6583, 1p |
| Abstrakt: |
A recent study conducted by Gilead Sciences Inc. has developed a methodology for deriving health-based exposure limits (HBELs) for leachables from polymeric components that interact with drug substances. The study addresses the challenge of limited toxicology data for leachables and proposes a conservative framework for estimating oral bioavailability and extrapolating it to parenteral routes. The research concludes that this read-across methodology provides a consistent and health-protective approach for deriving HBELs when toxicology data is limited. The study has been peer-reviewed and published in Regulatory Toxicology and Pharmacology. [Extracted from the article] |
| Databáze: |
Complementary Index |
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