Theoretical basis and suitable software if available (the free ones are warmly welcome!)
Hi, I want to say which signs would be determined adverse. For example, the high dose group bodyweight increased significantly but just by 5% compared with control, how do you think it would be considered adverse. Another example, Alopecia in the limb were often observed in rats, if the No. of amimals with this clinical signs was increased statistically, how to assess the NOAEL? Maybe we should set up a standard for determine the classification of adverse for the toxicology signs. Thanks.
Strictly speaking, you don't need any software or theorie for determining a NOAEL or LOAEL since these are the no or lowest OBSERVED adverse effect levels. That is, they are determined by the experimental design and always correspond to a dose level in the study. The only point of discussion could be (in some cases) what adverse is...
Yes, we need to discuss what adverse is. Statistically significant is not the only assessment way.
That's not the issue with NOAELs or LOAELS: there is no statistics there (unless you apply a model to estimate the real NAEL or LAEL). It's rather whether, for instance, effects like a small drop in body weight is adverse or whether a small increase in liver weight is adaptive rather than adverse. One could also discuss whether some transient effects are indeed adverse.
It's not quite as simple as reading the dose-response plot. The NOAEL is defined as the highest dose that is not statistically significantly different from the control response. Likewise, the LOAEL is defined as the lowest does that is statistically significantly different from the control response. Additionally, one can speak of a NOAEL or LOAEL from a specific study, but also of an overall NOAEL/ LOAEL derived from conosideration of multiple studies. Finally, the NOAEL and LOAEL require the determination of qualitative significance of the response.
Creo estar de acuerdo con el Sr. Peter, en cuanto a que sean sencillos, pienso que los mejores resultados se dan cuando pueden precisar "los casos", especialmente en trabajos clínicos
This is a very helpful article that I always refer to when faced by questions whether a sign or finding is adverse or not. http://tpx.sagepub.com/content/30/1/66.full.pdf
Use Benchmark Dose Software (BMDS) from US EPA
https://www.epa.gov/bmds
(The Benchmark Dose is the preferred regulatory method for dose-response analysis.)
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