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(log Kd $ 2:5; cf Table 74), are in second rank ordering We took it as a challenge to explain these anomalies in our optimized in vitro GIT model As Fig 758 indicates, our task was to explain the ordering of the eight probe molecules in the human in vivo target, but subjecting the eight probe molecules to each of the 50 PAMPA lipid models For each PAMPA model, the regression correlation coef cient, r2, was used to assess the appropriateness of the model 782 How Well Do Caco-2 Permeability Measurements Predict Human Jejunal Permeabilities Since the widely accepted in vitro permeability model in the pharmaceutical industry is based on the use of cultured cells, such as Caco-2 or MDCK, it was appropriate to analyze the regression correlation coef cients based on the comparisons of Caco-2 log Pe and the log Pe values based on the human jejunal measurements [56] Figure 759 shows a plot of log PHJP (human jejunal permeabilities) vs log e Caco-2 Pe taken from the literature, based on the work of more than 11 laboratories The r 2 for the correlation is 062 It is clear from the plot that some laboratories better predicted the HJP than other laboratories Figure 760 shows the plot of the results published by Artursson s group [506,512,603], where r 2 was calculated as 095, the most impressive value of all the comparisons It is noteworthy that naproxen, ketoprofen, and piroxicam were not available for the comparison in the Fig 760 plot

A process designed by, or under the supervision of, the issuer s principal executive and principal financial officers, or persons perform-

.

Artursson's Data [506,512,603]

Caco-2

ing similar functions, and effected by the issuer s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

783 How Well Do PAMPA Measurements Predict the Human Jejunal Permeabilities Table 723 shows the results for 47 speci c PAMPA models tested at pION, according the the scheme in Fig 758 The two columns on the right are the r 2 values in the comparisons The neutral-lipid models (10, 1A0, 20, 30, and 40) at pH 74 do not explain the permeability trend indicated in the human jejunal permeabilities [56] Octanol was least effective, with r 2 001 This should not be too surprising, since we did note that the appearance of naproxen, ketoprofen, and piroxicam at the top of the HJP ordering was unexpected Our expectations were based on the octanol water lipophilicity scale, which clearly does not correlate with the HJP trend Adding a sink condition to the 2% DOPC model (model 11) improves correlation (r 2 increases from 033 to 053) The addition of cholesterol to the 2% DOPC/dodecane system made the model unstable to the surfactant-created sink condition Introducing negative-charge phospholipids to the 2% DOPC at pH 74 improved the correlations signi cantly (models 50, 60, 70, 80, 90, 100) Sink conditions only marginally improved the correlations for the dodecylcarboxylic acid (11% DA) and phosphatidic acid (06% PA) models (models 61 and 71) The phosphatidylglycerol (PG) models (models 91 and 101) did not correlate well under sink conditions The modi ed Chugai model at pH 74 performed well (r 2 060), but was unstable under sink conditions Several egg lecithin models were tested at pH 74 The Avanti egg lecithin behaved differently from the Sigma-Aldrich egg lecithin, and was unstable under sink conditions when cholesterol was added The correlation coef cients were