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By simulating the data set with the parameters obtained from Eqn. 3, Eqn. 4 will yield as many F versus TIME pairs for the profiles as needed. In general, 10 pairs are sufficient for most straight lines. |
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3. In Vivo-In Vitro Correlation |
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STEP 6: Determine in vivo-in vitro correlation. |
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Plot the fractional system response time for dissolution (abscissa) versus the fractional system-response-time for AUC (ordinate) for the same fractional system response. Compute the coefficient of correlation, slope, and intercept (Fig. 32). |
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D. Discussion on System Response Correlation Concept |
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The computation and correlation of fractional system-response-time for dissolution and bioavailability provides a means for comparing analogous data sets in terms of how the product will perform both in the laboratory and in the biological (human) subject. This concept assumes that both the in vitro and in |
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Fig. 32
In vitro-in vivo correlation for six
phenobarbital tablet formulations
based on system response correlation
concept. |
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