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Purpose FDA’s bioequivalence recommendation for Zolpidem Tartrate Extended Release Tablets is the first to use partial AUC (pAUC) metrics for determining bioequivalence of modified-release dosage forms. Modeling and simulation studies were performed to aid in understanding the need for pAUC measures and also the proper pAUC truncation times. Methods Deconvolution techniques, In Vitro/In Vivo Correlations,...
Purpose. To develop an integrated absorption model for estimating the fraction of dose absorbed and determining the causes of poor oral drug absorption. Methods. Both analytical and numerical methods were used to estimate the fraction of dose absorbed. Results. An integrated absorption model was developed by considering transit flow, dissolution, and permeation processes, simultaneously....
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