Validation matrix

ICP-AES was validated for the simultaneous determination of Al, B, Ba, Be, Cd, Co, Cr, Cu, Fe, Li, Mn, Ni, Pb, Se, Sr and Zn in human serum in a clinical laboratory. The samples underwent digestion and yttrium was used as an internal standard. The LOD were as follows 0.002-0.003 (xM for Ba, Cd, Mn and Sr 0.014-0.07 (xM for Be, Co, Cr, Cu, Fe, Li, Ni, Pb and Zn and 0.2-0.9 (xM for Al, B and Se. The concentrations of Al, Be and Co in human serum were found to be above the LOD, while those of Cd, Cr, Ni and Pb were below the LOQ however, in case of acute intoxication with the latter elements the method is valid . Matrix effects were evaluated for ICP-AES analysis using solution nebulization and laser ablation (LA) techniques. The main matrix-related interferences stem from elements with a low second ionization potential however, these are drastically reduced when pure He is used as carrier gas. This points to Ar (the usual carrier) participation in the interference mechanism, probably by interacting with doubly charged species. ... 

The aseptic area validation matrix is summarized in the following table. Table 1 Aseptic Area Validation Matrix... 

General statement on acceptance criteria for all systems that are listed in the validation matrix. 

Accuracy can be defined as the fundamental ability any assay to measure the true concentration of an analyte. Pure standards in a valid matrix are often difficult to obtain, and the biological reactivity of less pure standards may not parallel their immunoreactivity in the assay. On the other hand, standards may be pure, but the assay antibody may react with similar molecules or fragments this cross-reactivity is discussed in detail below. Accuracy must be confirmed by comparison with an established method(s) using real samples. 

Other Performance Characteristics 7. Validation Matrix 8. Attachments and Forms... 

The quantitative method characteristics to be validated will depend on the nature of the method itself. The reader should refer to the table in ICH guideline Q2A, which lists those validation characteristics regarded as the most important for the validation of different types of analytical procedures. The design shown in the example validation matrix allows simultaneous assessment of accuracy, precision, and linearity. 

Factors are the major categories of a design. The levels of each factor are the values or versions that the factor can assume. Treatments are the combinations of the factor levels that are assigned to the experimental units. In our validation experiment there are factors of operator and day, each having two different levels. There are four treatments in the example validation matrix (refer to Table 1 in the Example Protocol). 

Overall, C. M., and Kleifeld, O. 2006. Validating matrix metalloproteinases as drug targets and anti-targets for cancer therapy. Nat. Rev. Cancer. 6 227-239. 

Garcia de Llasera, M. P. and Reyes-Reyes, M. L. 2009. A validated matrix solid-phase dispersion method for the extraction of organophosphorus pesticides from bovine samples. Food Chem. 114 1510-1516. 

OECD Participation in various OECD activities, e.g., code validation matrix. European Commission Activities on the safety of future reactors. 

Numerical Methods for Chemical Engineers Using Excel , VBA, and MATLAB the following are the results of various valid matrix multiplications ... 

OECD NUCLEAR ENERGY AGENCY, N. Aksan, D. Bessette, et al., Eds, CSNI Code Validation Matrix of Thermalhydraulic Codes for LWR LOCA and Transients, OECD/CSNI Rep. No. 132, Paris, 1987. 

Equation 159) is valid for every arbitaiy point in CS and for an aibitary set of nonzero adiabatic eigenvalues, (0), j N, hence the D matrix... 

We intend to show that an adiabatic-to-diabatic transformation matrix based on the non-adiabatic coupling matrix can be used not only for reaching the diabatic fi amework but also as a mean to determine the minimum size of a sub-Hilbert space, namely, the minimal M value that still guarantees a valid diabatization. 

Equation (D.6) is valid because the elecbonic coordinates are independent of the nucleai coordinates. Having this relation, we can calculate the following matrix element ... 

Once the format of the Fock matrix is known, the semiempirical molecular problem (and it is a considerable one) is finding a way to make valid approximations to the elements in the Fock matrix so as to avoid the many integrations necessary in ab initio evaluation of equations like Fij = J 4>,F4> dx. After this has been done, the matrix equation (9-62) is solved by self-consistent methods not unlike the PPP-SCF methods we have already used. Results from a semiempirical... 

One valid form of the input file is the z-matrix form usually associated with GAUSSIAN calculations... 

The method of standard additions can be used to check the validity of an external standardization when matrix matching is not feasible. To do this, a normal calibration curve of Sjtand versus Cs is constructed, and the value of k is determined from its slope. A standard additions calibration curve is then constructed using equation 5.6, plotting the data as shown in Figure 5.7(b). The slope of this standard additions calibration curve gives an independent determination of k. If the two values of k are identical, then any difference between the sample s matrix and that of the external standards can be ignored. When the values of k are different, a proportional determinate error is introduced if the normal calibration curve is used. 

The same relations (11) and (12) hold for the Gibbs free energy in the (N, p,T) ensemble. Equation (11) is also valid for a quanmm mechanical system. Note that for a linear coupling scheme such as Eq. (10), the first term on the right of Eq. (12) is zero the matrix of second derivatives can then be shown to be definite negative, so that the free energy is a concave function of the Xi. 

It is important to note, however, that all this is not free. The designer must invest the time to set up the cases and evaluate the results. Only the designer can make the final decision as to whether the cases and the comparisons are valid (a true representation of the plant). The computer printout is simply the results of matrix manipulation and should be considered suspect until given the designer s stamp of approval. 

The design verification plan should be constructed so that every design requirement is verified and the simplest way of confirming this is to produce a verification matrix of requirement against verification methods. You need to cover all the requirements, those that can be verified by test, by inspection, by analysis, by simulation or demonstration, or simply by validation of product records. For those requirements to be verified by test, a test specification will need to be produced. The test specification should specify which characteristics are to be measured in terms of parameters and limits and the conditions under which they are to be measured. 

A variation on the exact soiutions is the so-caiied seif-consistent modei that is explained in simpiest engineering terms by Whitney and Riiey [3-12]. Their modei has a singie hollow fiber embedded in a concentric cylinder of matrix material as in Figure 3-26. That is, only one inclusion is considered. The volume fraction of the inclusion in the composite cylinder is the same as that of the entire body of fibers in the composite material. Such an assumption is not entirely valid because the matrix material might tend to coat the fibers imperfectiy and hence ieave voids. Note that there is no association of this model with any particular array of fibers. Also recognize the similarity between this model and the concentric-cylinder model of Hashin and Rosen [3-8]. Other more complex self-consistent models include those by Hill [3-13] and Hermans [3-14] which are discussed by Chamis and Sendeckyj [3-5]. Whitney extended his model to transversely isotropic fibers [3-15] and to twisted fibers [3-16]. 

The effects of confinement due to matrix species on the PMF between colloids is very well seen in Fig. 1(c). At a small matrix density, only the solvent effects contribute to the formation of the PMF. At a higher matrix density, the solvent preserves its role in modulating the PMF however, there appears another scale. The PMF also becomes modulated by matrix species additional repulsive maxima and attractive minima develop, reflecting configurations of colloids separated by one or two matrix particles or by a matrix particle covered by the solvent layer. It seems very difficult to simulate models of this sort. However, previous experience accumulated in the studies of bulk dispersions and validity of the PY closure results gives us confidence that the results presented are at least qualitatively correct. 

Current option 136, 214 density matrix 263 l,2-dichloro-l,2-difluoroethane 24 dichloroethane 239, 242 dielectric constant 239 diffuse functions 99 difluoroethylene 45 dihedral angles 290 valid range 288 n,n-dimethylformamide 105 dipole moment 20... 

---