Pharmacostatistical model

In summary, the pharmacostatistical model developed in the population PK analysis provided an excellent basis for the description of the cetuximab concentration data, and demonstrated that the PK of cetuximab are not likely to be influenced by intrinsic or extrinsic factors, as indicated by the results of the covariate analysis. 

Grasela T, Sheiner L (1991) Pharmacostatistical modeling for observational data. J Pharmacokin Biopharm 19(3) 25S-37S... 

Rosenbaum SE. Effect of variability in hepatic clearance on the bioequivalence parameters of a drug and its metabolite simulations using a pharmacostatistical model. Pharm Acta Helv 1998 73 135-144. 

Step 6. With the appropriate pharmacostatistical models, population model building is performed using covariates retained in step 5 with the covariate selection level set at a= 0.005. The backward elimination for covariate selection in applied to each of the 100 bootstrap samples. The covariates found to be important in explaining the variablilty in the parameter of interest are used to build the final population PM model. 

One of the most difficult tasks facing a pharmacostatistical analyst is that of demonstrating whether a model is an accurate representation of the actual system being studied — whether the model is valid. If this cannot be shown, conclusions derived from the model will have little value. " When a model and its results are accepted by the scientific community as valid and are employed in decision-making processes, it can be called credible. Validation along with verification can occur at several... 

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