Point of departure (PoD) selection for the derivation of acceptable daily exposures (ADEs) for active pharmaceutical ingredients (APIs)

Published 2016 View Full Article

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Title
Point of departure (PoD) selection for the derivation of acceptable daily exposures (ADEs) for active pharmaceutical ingredients (APIs)
Authors
Keywords
Point of departure (PoD), Acceptable Daily Exposure (ADE), Permitted Daily Exposure (PDE), Cleaning validation, Cross-contamination, No-observed-adverse-effect-level (NOAEL), Lowest-observed-adverse-effect-level (LOAEL), Pharmacodynamics (PD), Pharmacokinetics (PK)
Journal
REGULATORY TOXICOLOGY AND PHARMACOLOGY
Volume 79, Issue -, Pages S48-S56
Publisher
Elsevier BV
Online
2016-05-25
DOI
10.1016/j.yrtph.2016.05.028

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