Robust Summaries

Supporting the compilation of robust summaries that document in a transparent way the use of in silico methods for specific regulatory purposes. 

To avoid duplication of effort, this database of robust summaries of (Q)SAR models should be made freely available and considered as a reference source for the use of (Q)SAR approaches in a regulatory context. 

HaSDR rules require producers and importers to submit to the U.S. EPA copies and lists of certain types of unpublished health and safety studies for the listed chemicals.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. 

OECD, Guidance for Developing Robust Summaries for SIDS Dossiers (Document number ENV/JM/EXCH(99), 13 (Oct.8 1999), ava/iifcfe at http //www.epa.gov/chemrtk/pubs/general/ robsumgd.htm. 

OECD, Guidance for Developing Robust Summaries for SIDS Dossiers... 

Instruments based on the contact principle can further be divided into two classes mechanical thermometers and electrical thermometers. Mechanical thermometers are based on the thermal expansion of a gas, a liquid, or a solid material. They are simple, robust, and do not normally require power to operate. Electrical resistance thermometers utilize the connection between the electrical resistance and the sensor temperature. Thermocouples are based on the phenomenon, where a temperature-dependent voltage is created in a circuit of two different metals. Semiconductor thermometers have a diode or transistor probe, or a more advanced integrated circuit, where the voltage of the semiconductor junctions is temperature dependent. All electrical meters are easy to incorporate with modern data acquisition systems. A summary of contact thermometer properties is shown in Table 12.3. 

In summary, such simple classification schemes for drug-likeness can, in a very fast and robust manner, help to enrich compound selections with drug-like molecules. These filters are very general and cannot be interpreted any further. Thus, they are seen rather as a complement to the more in-depth profiling of leads and drugs by using molecular properties and identifying trends in compound series. 

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. 

In summary, there is now convincing evidence that Ra is added to the mantle wedge source of arcs by fluids and that the most recent of these additions must have occurred less than 8 kyr ago. The evidence depends on the magnitude of ( Ra/ °Th) and the quality of its correlation with subduction parameters. The evidence is most robust for oceanic arcs and it usually hinges on data for a few volcanoes, usually the ones with the lowest Th concentrations. 

In summary, use of biorelevant media to determine solubility in the upper gut combined with assessment of formulations with respect to robustness and ability to protect the drug from precipitation are key to an efficient development process for compounds that are poorly soluble and weakly basic. 

FIGURE 4.16 Summary statistics of the result of robust regression for the ash data. 

Summary. In this chapter the control problem of output tracking with disturbance rejection of chemical reactors operating under forced oscillations subjected to load disturbances and parameter uncertainty is addressed. An error feedback nonlinear control law which relies on the existence of an internal model of the exosystem that generates all the possible steady state inputs for all the admissible values of the system parameters is proposed, to guarantee that the output tracking error is maintained within predefined bounds and ensures at the same time the stability of the closed-loop system. Key theoretical concepts and results are first reviewed with particular emphasis on the development of continuous and discrete control structures for the proposed robust regulator. The role of disturbances and model uncertainty is also discussed. Several numerical examples are presented to illustrate the results. 

In broad summary, a reasonable measure of residual effect for uptake by plant roots or control of soil-borne organisms requires moderate adsorption (which expresses the partition between solid and liquid phases) and a small fraction in the air-phase to allow some movement in dry soil conditions and some degree of vapour action. This last property is particularly important in ensuring a robustness of performance under varying climatic conditions which may... 

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. 

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. 

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