نتایج جستجو برای: noael
تعداد نتایج: 385 فیلتر نتایج به سال:
The FDA guidance focuses on the use of the NOAEL to establish the maximum recommended starting dose. The majority of NOAEL has been described inaccurately or incompletely in final reports for 90-days repeated dose toxicity test based on GLP (good laboratory practice) regulation. This is the most serious one of reasons for why most pharmaceutical companies targeting global markets have disregard...
One approach to derive a data-based assessment factor (AF) for subchronic-to-chronic extrapolation is to determine ratios between the NOAEL(subchronic) and NOAEL(chronic) for the same compounds. Instead of using ratios of NOAELs, the distribution can also be estimated by ratios of subchronic and chronic Benchmark Doses (or Critical Effect Doses, CEDs, for continuous data). In this study 314 dos...
Barium and Compounds Substance File (IRIS Ba File). The influential information contained in this file fails to comply with the OMB " Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies ". The information disseminated in EPA's IRIS Barium and Compounds file directly contradicts the information published by EPA i...
OBJECTIVES Both environmental and occupational exposure limits are based on the no-observed-adverse-effect level (NOAEL), lowest-observed-adverse-effect level (LOAEL) or benchmark dose (BMD) deriving from epidemiological and experimental studies. The aim of this study is to investigate to what extent the NOAEL values for organic compounds responsible for liver toxicity calculated based on their...
The determination of the value of the no-observed-adverse-effect level (NOAEL) when observed responses can be categorized by severity (categorical data) and sample sizes are small is discussed. The common situation of only two categories, where only the presence or absence of an effect is observed, is addressed first (dichotomous data). Three tests for dichotomous data are critically examined, ...
The use of no observed adverse effect levels (NOAELs) as a way of interpreting toxicology studies carries a number of problems, and the benchmark dose (BMD), or its lower confidence limit have been proposed as potential replacements. In practice, the theoretical advantages of the BMD approach are often outweighed by the practical disadvantages posed in a regulatory context. Attempts to seek con...
Cohen's lung cancer mortality data, from his test of the LNT theory, do not extend to the no observed adverse effects level (NOAEL) above which inhaled radon decay products begin to induce excess lung cancer mortality. Since there is concern about the level of radon in homes, it is important to set the radon limit near the NOAEL to avoid the risk of losing a health benefit. Assuming that dogs m...
The setting of occupational exposure limits (OELs) are founded in occupational medicine and the predictive toxicological testing, resulting in exposure-response relationships. For compounds where a No-Observed-Adverse-Effect-Level (NOAEL) can be established, health-based OELs are set by dividing the NOAEL of the critical effect by an overall uncertainty factor. Possibly, the approach may also b...
The benchmark dose (BMD) is the dose of a substance that is expected to result in a prespecified level of effect, the benchmark response level or BMR. It is a general approach to characterizing dose response, applicable to any toxicant and endpoint. A BMD is conceptually superior to a “no observed adverse effect level” (NOAEL) for this purpose because of being less determined by experimental de...
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