Model building procedure

Badger, J. (2003). An evaluation of automated model building procedures for protein crystallography. Acta Crystulhgr. D 59, 823-827. 

Data analysis method Stating the software, model building procedures, model diagnostics, structural model, covariate model, stochastic model, and sensitivity analysis to be used and how the evaluation of the model is to be conducted... 

From the perspective of the time required for modeling, it is apparent that a very important aspect of the data collection phase is ensuring that the pharmacometri-cian takes the time to prepare for the modeling. This preparatory work should include finalization of the data analysis plan, preparation of model building procedures, and construction of a template or templates for the report. In this way, the data collection phase can shorten the time required for modeling. 

The subject population covariate plays a special role in PK similarity assessment, similar to that of formulation in BE assessment. That is, if the influence of formulation on the rest of the parameters Ka, V, CL, etc.) is not adequately represented in the model, then the model will underrepresent the formulation influence on the predictions of PK parameters and may bias the BE assessment results. To further illustrate this, the conventional model building procedure might find the formulation factor insignificant in the model, and if the final model contains no formulation factor, it will predict the AUC and Cmax ratios to be 1 with certainty, that is, producing confidence intervals of length 0. Thus, BE would have to be declared by default. This is clearly unacceptable from the standpoint of traditional BE assessment, which often finds the formulation term insignificant in ANOVA but always produces confidence intervals of positive lengths for the AUC and Cmax ratios. 

Model building has shown (107) that the alcoholate ion can bind to zinc in the apoenzyme structure in such a way that the hydrogen atom which is to be transferred is sufiBciently close to the C-4 atom of the nicotinamide ring for direct transfer to occur (see Fig. 19). The known position and conformation of boimd ADP-ribose was used in the model building procedure (Section II,C,3,a). It was assumed that the remaining part of NAD+ had the same conformation in LADH as in LDH (136). 

Feng HS, Menq CH (1994) The prediction of cutting forces in the ball end milling process model-I. FOTmulatirai and model building procedure. Int J Mach Tools Manuf 34 697-710... 

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