Christos Reppas

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ince the Biopharmaceutics Classification System (BCS) was introduced several years ago, it has become a benchmark in the regulation of bioequiva-lence of oral drug products both in the United States and abroad (1). The concept behind the BCS is that if two drug products yield the same concentration profile along the gastrointestinal (GI) tract, they will(More)
Evaluate the impact of luminal micellar phase on passive permeability of five lipophilic (1.9 ≤ clogP  ≤ 9.0) small molecules using biorelevant media and evaluate the impact of luminal coarse lipid particles on danazol permeability after oral administration of a triglyceride solution to fed adults using PAMPA. Permeability of carbamazepine, furosemide,(More)
Biorelevant in vitro performance testing of orally administered dosage forms has become an important tool for the assessment of drug product in vivo behavior. An in vitro performance test which mimics the intraluminal performance of an oral dosage form is termed biorelevant. Biorelevant tests have been utilized to decrease the number of in vivo studies(More)
To develop an in vitro methodology for prediction of concentrations and potential precipitation of highly permeable, lipophilic weak bases in fasted upper small intestine based on ketoconazole and dipyridamole luminal data. Evaluate usefulness of methodology in predicting luminal precipitation of AZD0865 and SB705498 based on plasma data. A(More)
The objectives of this study were twofold. First, to clarify the applicability of the similarity factor, f(2), the difference factor, f(1), and the Rescigno index, xi(i), in the comparison of cumulative drug vs. time data sets. Second, to assess the possibility for these indices to be used on a confidence interval basis. Theoretical profiles as well as(More)
Evaluate the impact of reduced gastric acid secretion after administration of two acid-reducing agents on the physicochemical characteristics of contents of upper gastrointestinal lumen of fasted adults. Eight healthy male adults, fasted from food for 12 h, participated in a three-phase crossover study. Phase 1: No drug treatment prior to aspirations. Phase(More)
Characterize the contents of distal ileum and cecum in healthy adults under conditions simulating the bioavailability/bioequivelance studies of drug products in fasted and fed state. Twelve males participated in a two-phase crossover study. Phase I: subjects remained fasted overnight plus 4.5 h in the morning prior to colonoscopy. Phase II: subjects(More)
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