Supporting data

As of this writing, it has not been possible to use the seismic data which defines the volume of the reservoir to also determine the joint stmcture. Extended flow testing is the most direct measure of the efficiency and sustainabiUty of energy recovery from the reservoir. The use of chemical tracers in the circulating fluid can also provide valuable supporting data with regard to the multiplicity of flow paths and the transit time of fluid within the reservoir (37). 

The chromatography literature contains a vast amount of dispersion data for all types of chromatography and, in particular, much of the data pertains directly to GC and LC. Unfortunately, almost all the data is unsuitable for validating one particular dispersion equation as opposed to another. There are a number of reasons for this firstly, the necessary supporting data (e.g., diffusivity data for the solutes in the solvents employed as the mobile phase, accurate distribution and/or capacity factor constants (k")) are not available secondly, the accuracy and precision of much of the data are inadequate, largely due to the use of inappropriate apparatus with high extracolumn dispersion. 

This report documents the development of data on the severity as well as the frequency of accidents involving truck, rail, and air transport. Volume 1 includes a summary giving the probability of occurrence of accidents as a function of accident severity. Subsequent Volumes give supporting data, calculations and analysis. 

Records. The manufacturer shall keep records of all calculations and tests. When requested by prospective purchaser or by a user of the equipment, the manufacturer shall examine the details of computations, drawings, tests, or other supporting data necessary to demonstrate compliance with the specification. It shall be understood that such information is for the sole use of the user or prospective purchaser for checking the API rating, and the manufacturer shall not be required to release the information from his custody. 

The microprocessor should also be able to support modem communication with remote computers. This feature will enable multiple plant operation and direct access to third party diagnostic and analysis support. Data can be transferred anywhere in the world using this technique. Not all predictive maintenance systems use a true RS 232 communications protocol or support modem communications. These systems can severely limit the capabilities of your program. The various predictive maintenance techniques will add other specifications for an acceptable data acquisition unit. 

This collection of worksheets (about three per chapter) is for students to use in collaborative groups. Designed to stimulate group activity and discussion, the questions provided on each worksheet are equally conceptually and quantitatively oriented. Also included are instructions for use, information on how to guide student discussion, and supporting data on the success of cooperative learning at the University of Connecticut... 

UNESCO (1981). Background papers and supporting data on the Practical Salinity Scale 1978. UNESCO Technical Papers in Marine Science No. 37. UNESCO. 

Notice Approaches for the Application of Physiologically-Based Pharmacokinetic (PBPK) Models and Supporting Data in Risk Assessment E-Docket ID No. ORD-2005-0022. Fed Reg July 28, 2005 70 (144) 43692-43693. 

The effort required to establish identity of a nitrosamine in an environmental sample depends on the nature of the problem and the specificity of the primary detection system. TEA response is much stronger evidence of identity than response from a flame ionization or nitrogen-specific detector. If TEA response is supported by chemical (9) or ultraviolet photolysis (8) supporting data, identification is adequate for many... 

The committee concluded that the best evaluation for this purpose was a 90-day study in rats. An ADI of 0 to 2 mg/kg body weight was allocated based on a NOEL of 200 mg/kg body weight per day (the highest dose tested in the study) and a safety factor of 100. Although the ADI was based on the results of a shortterm study, the supporting data and lack of effects at much higher doses in some studies (e.g., a study of developmental toxicity) indicated that the safety factor of 100 was appropriate. 

Other supportive data fields go here to verify that the event happened. ... 

The compatibility of the active ingredient with other active ingredients and excipients should be demonstrated. Preformulation study reports often provide useful relevant information. Preliminary stability study reports may be used as supporting data. 

Where an unusual excipient is chosen, or where an established excipient is chosen for a dosage form that results in its administration by a novel route of administration, then additional data will need to form part of the application. In effect, a novel excipient will need to be supported by data similar to those required for a new drug, with full supporting data including composition, function, and safety. Novel excipients include the components of the matrix in prolonged release products, new propellants, and new permeability enhancers. The exception to this need for extensive supporting data would be for a material already approved for food use and administered by the oral route or a material already approved for cosmetic use with a topical route of administration. In all cases the quality of the excipients has to be described adequately and shown to be satisfactory (which will depend on its role). 

In the case of heat sterilization processes, the supporting data required include heat distribution and heat penetration studies (usually at least three runs at the minimum process parameters), with calculation of... 

The FDA evaluates each tumor marker test against its own labeling claims as to how well it performs and compares it with other cleared and marketed devices identified in the 510(k) submission. The intended use claim for monitoring must be supported by valid scientific and clinical data. Labeling a tumor marker test for a particular claim can mean that the testing system may have to show supporting data for that claim. For example, a tumor marker proposed for a monitoring claim will require laboratory and clinical data to support that claim (4,5). 

Figure 1 is based upon experience gathered since the 1940s. Supporting data were obtained from a variety of commercial processes and laboratory experiments (see the references to Figure 1). While temperature and hydrogen partial pressure data were not always known precisely, the accuracy is sufficient for commercial use. Satisfactory performance has been plotted only for samples or equipment exposed for at least one year. Unsatisfactory performance ftom laboratory or plant data has been plotted regardless of the length of exposure time. The chemical compositions of the steels in Figure 1 should conform to the limits specified for the various grades by ASTM/ASME.

No effects were observed at a dose of 3.1 mg/kg/day. However, because this study lacks details and there is no supporting data, no intermediate-duration MRL was derived. Additional intermediate-duration oral studies of hydrogen sulfide are needed to provide support for this study. 

Data Adequacy The key study was well designed, conducted, and documented. Values were presented graphically. Supporting data were sparse, probably because aniline is not a vapor at room temperature, and poisonings have involved contact with the liquid. Although human data are sparse, it is believed that a total uncertainty factor of 100 is protective of human health. Because aniline is absorbed through the skin, which increases the systemic toxicity, direct skin contact with the liquid would be additive and result in onset of adverse effects at airborne concentrations below the respective AEGL values. Therefore, direct skin contact with the liquid should be avoided. 

The evaluation of hazards in a process starts at the initial screening of the process parameters. Several technical issues that will need more attention will arise from this screening procedure. Hazard evaluation procedures, however, are no substitutes for engineering codes of practice and for design standards, but are used as supplementary ideas and concepts. A prerequisite for any process hazard evaluation is a full knowledge of the chemistry of the process (including potential unwanted side reactions) with supporting data. 

Figure 9.3 Rh 3d5/2 binding energy versus particle size for half spherical rhodium particles on an alumina support (data from Huizinga el al. [14], and from Kip et al. [15], see also Fig. 6.18).

Data adequacy The key study was well conducted and documented. Supporting data include both human and animal studies. Animal studies covered acute, subchronic, and chronic exposure durations and addressed systemic toxicity as well as neurotoxicity, reproductive and developmental effects, cardiac sensitization, genotoxicity, and carcinogenicity. Other effects in animal studies occurred at much higher concentrations or with repeated exposures the latter are not relevant for setting short-term exposures. No effects other than narcosis occurred in rats and mice exposed at 200,000 ppm for various periods of time. Adjustment by a total UF of 10 results in a higher value (20,000 ppm) than from the cardiac sensitization test with dogs. ... 

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