Biologically plausible

It is biologically plausible that exposure to a sufficient level of an oestrogenic chemical could cause harmful biological effects. However, it is far more difficult to establish that environmental oestrogens are responsible for adverse effects on... 

In summary, while only the NEI initiated AREDS II study is a large enough RCT to have the potential to provide definitive evidence as to whether the macular xanthophylls can indeed reduce the risk of AMD, the evidence available to date that lutein and zeaxanthin could contribute to this is not only biologically plausible but also supported by various experimental, epidemiological, and small-scale clinical studies. Although the benefits of lutein and zeaxanthin in this respect may be moderate to small, their safety is well documented. 

Fruits and vegetables have historically been considered rich sources of some essential dietary micronutrients and fibers, and more recently they have been recognized as important sources for a wide array of phytochemicals that individually, or in combination, may benefit health (Stavric 1994 Rechkemmer 2001). Therefore, some people have conferred on fruits and vegetables the status of functional foods. There are many biologically plausible reasons for this potentially protective association, including the fact that many of the phytochemicals act as antioxidants. 

One important criterion for determining whether an association is causative is whether it is biologically plausible. Although a justification of the biological plausibility of each of our observed associations is beyond the scope of this report, it is rather common knowledge that abundant evidence from other studies confirms the plausibility of a causative link between meat use and coronary disease (22). However, this study is the first major observational study to clearly show this relationship among U.S. subjects. The associations between meat and diabetes are certainly plausible, but there is considerably less evidence from other experimental or observational studies to substantiate such a relationship. 

All known human carcinogens that have been smdied adequately for carcinogenicity in experimental animals have produced positive results in one or more animal species (lARC 2006). lARC (2006) also states that although this association cannot establish that aU substances that cause cancer in experimental animals also cause cancer in humans, it is biologically plausible that substances for which there is sufficient evidence of carcinogenicity in experimental animals also present a carcinogenic hazard to humans. 

Check whether any assumptions, conclusions, or intermediate outputs conflict with common sense or biological plausibility. 

These sections include brief discussions of statistics, data presentation, and terminology. The two major points regarding statistics are that the litter (or mating pair) is the unit of comparison, and that significance tests can be used only as a support for the interpretation of results—the interpretation itself must be based on biological plausibility. That the litter is the unit of comparison is a guiding principle ofvirtually all texts on the subject (e.g., see ref 7). It should be stated that this guideline does not require that statistical analyses be performed on every study. It is implied that statistical analyses should be used as a tool for interpretation. 

Detection of developmental effects induced by endocrine system disruption is discussed in chapter 5. Significant effects on any of these measures may be considered adverse if the results are consistent and biologically plausible. 

Burdakov D., and Verkhratsky A. 2006 Biophysical re-equilibration of Ca2+ fluxes as a simple biologically plausible explanation for complex intracellular Ca2+ release patterns. FEBS Lett 380, 463-468. 

By the time a therapeutic confirmatory trial is appropriate, it should be possible to state a single primary objective (or perhaps two if the sponsor really feels that this is appropriate) that is clinically relevant and biologically plausible. One primary objective also means that sample-size estimation can be based on that objective and the associated estimated treatment effect of interest (recall the discussions in Chapter 9). 

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