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

出版年份 2016 全文链接

标题

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

作者

关键词

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)

出版物

REGULATORY TOXICOLOGY AND PHARMACOLOGY

Volume 79, Issue -, Pages S48-S56

出版商

Elsevier BV

发表日期

2016-05-25

DOI

10.1016/j.yrtph.2016.05.028

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