Robust study summary

Review of the quality of data, identification of data gaps, preparation of SIDS Dossiers including Robust Study Summaries and SIDS Testing Plans... 

Once all the data elements of the SIDS for the sponsored chemical (a full SIDS chemical) have been obtained, the SIDS Initial Assessment Report (SIAR) is prepared based on the information in the full SIDS Dossier, including the robust study summaries (Section 2.3.1.4). The SIAR draws conclusions on the potential hazard(s) and recommendations on the need for further work. 

EC) No. 440/2008, (43)). Deviations from the standard protocols should be reported in the robust study summary. Moreover, if a study does not comply with any specific guideline, all relevant information on the study design should be included in the summary so that the regulator can make conclusions on the reliability and significance of the study. 

ECHA (2010) Practical guide 3 How to report robust study summaries. ECHA-10-B-06-EN... 

In summary, a key aspect to the utility of U-series isotopes in the study of arc lavas is that whereas Th and Pa are observed and predicted to behave as relatively immobile high field strength elements (HFSE), Ra and (under oxidizing conditions) U behave like large ion lithophile elements (LILE) and are significantly mobilized in aqueous fluids. Fluid-wedge interaction will only serve to increase these fractionations. Just how robust the experimental partition coefficients are remains to be established by future experiments. 

The NCO should not be a mere repetition of the data presented in the narrative summaries a more analytical approach is needed to arrive at a robust risk-benefit balance. Any issues should be addressed and instances where the development program has deviated from the standard study designs or guidelines should be explained and justified. Negative findings should not be glossed over or omitted but should be dealt with openly and in an unbiased manner. Care should be taken to ensure that the NCO and written summaries are in agreement and do not contain any contradictions. 

The addition of lithium in treating major depressive disorder in patients unresponsive to antidepressant drugs has been discussed, and it has been noted that about 50% of patients respond to lithium augmentation in 2 1 weeks (71), while others have pointed to the absence of controlled data for this treatment in bipolar depression, while nevertheless recommending its use (72). In summary, there are data that support the use of lithium augmentation for treatment-resistant unipolar major depression. However, the data are not robust and are based on only a few hundred patients. Placebo-controlled studies of lithium augmentation for treatment-resistant bipolar depression are lacking (73). 

In the proteomic analysis of the brain, two-dimensional gels for protein separation, followed by matrix-assisted laser desorption ionization time-of-flight mass spectrometry for protein identification, have mainly been employed. This classical proteomics approach allows for the quantification of changes in protein levels and modifications. Simultaneously, it is a robust, well-established method that finds wide application in the study of biological systems. In this article, we provide a description of the protocols of the proteomic analysis used in our laboratory and a summary of the major findings from our group and other neuroproteomics groups. 

Multivariate methods of mathematical analysis are needed that are robust, non-subjective and make use of all spectral information. A summary of reports using multivariate methods for the analysis of biomedical MRS data is listed in Table 1. In these studies, however, the requirements for a large patient cohort, data preprocessing/reduction and/or validation of classifiers are not met. 

Biological assays are often noisy and laborious. With careful application of experimental design, cell culture bioassays can be made quite accurate and precise. The core information needed for validation can come from two experiments. One experiment studies accuracy and precision followed by a variance component analysis and a summary table that describes the expected performance of the system at various levels of replication. A second experiment uses a minimal fractional factorial design to study robustness, followed by a comparison of confidence intervals on effect sizes with a previously established indifference zone. 

HaSDR rules require producers and importers to submit to the U.S. EPA copies and lists of certain types of unpublished health and safety studies for the listed chemicals. Submitters under the HaSDR rule are also requested to provide robust summaries of health and environmental effects studies. In addition, when the ITC designates chemicals for testing, the U.S. EPA is required to initiate proceeding under a TSCA Section 4(a) test rule, if the PAIR and HaSDR data trigger a finding of unreasonable risk of injury to health or the environment. 

A validation plan should be written before the initiation of the prestudy validation experiments. Alternatively, reference to an appropriate SOP can be made to ensure that a documented outline exists for the experiments required for prestudy validation. This plan can be a stand-alone document or can be contained in a laboratory notebook or some comparable format. The documentation should include a description of the intended use of the method under consideration and a summary of the performance parameters to be validated that should include, but may not be limited to, standard curve, precision and accuracy, range of quantification, specificity and selectivity, stability, dilutional linearity, robustness, batch size, and run acceptance criteria. The plan should include a summary of the proposed experiments and the target acceptance criteria for each performance parameter studied. 

Rock N.M.S., 1988b, Summary statistics in geochemistry a study of the performance of robust estimates. Math. GeoL, 20, 243-275. 

The WHO task group used the updated estimates for those studies with reanalyzed data. Estimates of the effeet of PMio on all-cause mortality were taken from 33 separate European cities or regions. The summary relative risks of all cause deaths, deaths from cardiovascular and from respiratory causes for these 33 results is shown in Eig. 3. 21 of theses estimates were taken from the APHEA 2 study (Katsouyanni et al. 2001) and hence the summary estimate derived from this review is dominated by this multicity study. There were no cause specific mortality data available from the APHEA project at the time of met analysis and the summary risk estimate for cause specific mortality was calculated on the basis of 17 multicity studies mainly conducted in France, Italy and Spain. Therefore care has to be taken interpreting the differences in the risk estimates. The estimates for all-cause mortality and cause-specific mortality taken from European studies are comparable to those reported from the NMMAPS based upon the 20 largest cities in the United States (Samet et al. 2000a) (Fig. 3). Air pollution risk estimates were relatively robust to different modeling approaches (Samoli et al. 2008). 

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