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The no-observed-adverse-effect-level in drug safety evaluations: use, issues, and definition(s)

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title

The no-observed-adverse-effect-level in drug safety evaluations: use, issues, and definition(s) (English)

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author name string

Michael A Dorato

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1

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Jeffery A Engelhardt

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2

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language of work or name

English

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publication date

August 2005

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published in

Regulatory Toxicology and Pharmacology

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volume

42

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issue

3

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page(s)

265-74

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cites work

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Reference dose (RfD): description and use in health risk assessments

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Regulatory decision strategy for entry of a novel biological therapeutic with a clinically unmonitorable toxicity into clinical trials: pre-IND meetings and a case example

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Does the animal-to-human uncertainty factor incorporate interspecies differences in surface area?

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Improved method for selection of the NOAEL

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Hormesis as a biological hypothesis

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Hormesis: a highly generalizable and reproducible phenomenon with important implications for risk assessment.

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The hormetic dose-response model is more common than the threshold model in toxicology

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Toxicology rethinks its central belief

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Hormesis--basic, generalizable, central to toxicology and a method to improve the risk-assessment process

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Paradigm lost, paradigm found: the re-emergence of hormesis as a fundamental dose response model in the toxicological sciences

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Regulatory history and experimental support of uncertainty (safety) factors

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Statistical properties of the NOAEL.

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Recognition of adverse and nonadverse effects in toxicity studies

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Concordance of the toxicity of pharmaceuticals in humans and in animals

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Hormesis and toxicological risk assessment

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The role of pharmacological profiling in safety assessment

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The benchmark approach applied to a 28-day toxicity study with Rhodorsil Silane in rats. the impact of increasing the number of dose groups

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Identifiers

DOI

10.1016/J.YRTPH.2005.05.004

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PubMed publication ID

15979222

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ResearchGate publication ID

7765025

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(Q28258363)

The no-observed-adverse-effect-level in drug safety evaluations: use, issues, and definition(s)

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