Data Acceptance

From a deterministic perspective, quantitative engineering data are either acceptable or unacceptable. For instance, when the minimum low-cycle 

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Following the review, audit, and acceptance process, the preparer needs to be notified of data acceptance or rejection. With this feedback, the preparer can make necessary corrections to provide higher quality data in the future. 

The American Petroleum Institute (API) has established standards for vibration levels. Unlike the Rathbone chart, which presents relative vibration data, the API standards are actual shaft displacement as measured with a displacement probe. Based on the API data, acceptable vibration can be defined by ... 

With respect to method application, once validation has been satisfactorily completed, there is little question that use of the analytical method in worker safety and re-entry studies falls under the full requirements of the GLP Standards. In addition, there should be an adequate level of quality control measurements taken in conjunction with the specimens so as to provide for a meaningful assessment of accuracy and precision, as well as verification of freedom from artifactual interferences. Along with these measurements there needs to be reasonably rigid data acceptance criteria in place (usually established during validation) which are consistently applied during the course of the specimen analytical phase of the study. 

Tables 3.1, 3.2 and 3.3 compiled by Povarennykh (1963) specify the initial data accepted for the calculation of hardness from formulae (3.5) and (3.6). As the ratio WJWa increases, the coefficient a decreases (Table 3.1). For compounds with ratios inverse to those given in the table, i.e., for compounds having a so-called antistructure, the coefficient a will be exactly the same, e.g., 1/2 and 2/1. In both cases, x — 80. The link attenuation coefficient / varies over a relatively narrow range, usually between 0.7 and 1.0 (Table 3.2). This coefficient requires the state of lattice linkage to be considered in each case, and like coefficient a it depends on the type of compound involved. For various types of compounds, the values of the coefficient / may be lower taking as an example minerals in the pyrite and skutterudite group, they are as follows for compounds 2/2—0.60, for 3/3—0.48 and for 4/4—0.39. The values of the coefficient y grow proportionally with coordination number (Table 3.3). The constancy of the coefficient y depends on the constancy of the coordination number which is influenced by the valence ratio of electropositive and electronegative atoms. Lattice spacings, state of chemical bonds and electron-shell structure, and for complex compounds, also the degree of action of the remain-...

Finally, it is important to note that, while both the JOE and LBNL model fit the Mallik production data acceptably, as shown in Table 7.15 both extrapolate to significantly different long-term production values, perhaps due to the short-term and transient nature of the Mallik production test. 

Strict criteria should be applied to the process of data acceptance for rule development, and ideally, the effects of metabolism should be known or be predictable. It is also important that toxicological information is correctly interpreted and this can be achieved by a close cooperation among toxicologists, chemists, and experts in computer programming (Figure 9.5). 

One way in which orphan products are made available is for the OPD to support clinical research to determine whether the products are safe and effective. All funded studies are subject to the requirements of the FD C Act and the corresponding Code of Federal Regulations. The goal is the clinical development of products for use in rare diseases or conditions in which either no current therapy exists or current therapy would be improved. Grants are offered for studies intended to provide data acceptable to the agency that will either result in or substantially contribute to approval of these products. The FDA asks applicants to keep this in mind. It requires an explanation in the Background and Significance section of the application of how their proposed study will either facilitate product approval or provide essential data needed for product development. 

Nieuwoudt, I. Vapour-liquid equilibrium and density data for the system n-butane + hexacontane, Journal of Chemical and Engineering Data. Accepted for publication. 

The NAC/AEGL Committee estimates the range in variability of response to specific chemical exposures primarily on the basis of quantitative human data. Acceptable experimental data are more likely to be available for AEGL-1 and AEGL-2 endpoints than for AEGL-3 endpoints. For example, numerous studies have considered induction of bronchospasm after controlled exposmes to sulfur dioxide (SO2) in asthmatic and nonasthmatic individuals (see references below). There is marked individual variability in the severity of reaction to inhalation of low concentrations of SO2. Asthmatics, individuals with hyper-reactive airways, smokers, and those with chronic respiratory or cardiac disease respond at relatively lower concentrations (Aleksieva 1983 Simon 1986). Susceptibility may also be increased in people over 60 years of age, but reports have not been consistent (Rondinelli et al. 1987 Koenig et al. 1993). By contrast, comparable human data for AEGL-3 tier concentrations are limited to anecdotal case reports. 

M. Frere and G. De Weireld, High pressure and high temperature excess adsorption isotherms of Ni, CH4 and CsHg on activated carbon, J. Chem Eng. Data, accepted for publication in Chem. Eng. Data. 

To see if the model fits the data acceptably, one tests the hypothesis that the residuals in Si and Se are samples from normal distributions with equal variances and expected value zero. On this hypothesis, the predictive probability of obtaining a sample variance ratio / larger than the realized value F is... 

Classification as a carcinogen is made on the basis of evidence from reliable and acceptable methods, and is intended to be used for chemicals which have an intrinsic property to produce such toxic effects. The evaluations should be based on all existing data, peer-reviewed published studies and additional data accepted by regulatory agencies. 

HT Karnes, C March. Precision, accuracy and data acceptance criteria in bio-pharmaceutical analysis. Pharm Res 10 1420—1426, 1993. 

Test Cases / Test Data / Acceptance Criteria... 

All data accepted after technical scrutiny were statistically evaluated none were rejected on a statistical basis. The certified values are given in Table 6.4. During the course of this certification some laboratories individually determined other elements. These results are given as indicative values in the certification report [4]. 

In all batch cell experiments, data acceptability limits were... 

Table 6.23 Data acceptability criteria for toxicity testing samples...

Method validation is the process of documenting or proving that an analytical method provides analytical data acceptable for the intended use. 

It is a requirement that expiry specifications must be consistent with any data accepted by the Department in connection with product registration and with any statutory standard applicable to the product... 

An unresolved point of contention is the extent to which undetectable results should be reported. One view is that all data accepted after review must be reported. Values that are statistically indistinguishable from zero, including negative results, should be included to permit subsequent data review, analysis, and numerical treatments, including summing or averaging by collection location or time. The opposing view proposes a reader-friendly table that presents only the detected values, while all other results are stated to be undetectable. One resolution is to... 

The OQ protocol is executed once the system has been loaded with the operational data, accepting that a final data migration may be required to capture updates occurring during the test period. This process may often be referred to as "conference testing" or the "conference room pilot". 

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