Kubilay Dogan Kilic1, Yigit Uyanikgil1,2, Emel Oyku Cetin3 and Mehmet Turgut4* 1Department of Histology and Embryology, Ege University, School of Medicine, Izmir, Turkey 2Cord Blood, Cell-tissue Research and Application Center, Ege University, Izmir, Turkey 3Department of Biopharmaceutics and Pharmacokinetics, Ege University, Izmir, Turkey 4Department of Neurosurgery, Adnan Menderes University ...

Department of Clinical Pharmacy and Biopharmaceutics, Mie University Graduate School of Medicine (K.I., Y.H., T.I., M.O.), Tsu, Mie 514-8507, Japan Department of Pharmacy, Mie University Hospital (K.I., T.E., Y.M., T.I., M.O.), Tsu, Mie 514-8507, Japan Faculty of Pharmaceutical Sciences, Suzuka University of Medical Science, Suzuka (C.K.), Mie 513-8670, Japan Department of Pulmonary and Critica...

Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics (PBPK/PBBM) emerged as particularly useful tool formulation development. PBPK/PBBM facilitated strategies increasingly evaluated over the past few years, demonstrated by several reports ...

Literature data related to the Biopharmaceutics Classification System (BCS) are presented on verapamil hydrochloride, propranolol hydrochloride, and atenolol in the form of BCS-monographs. Data on the qualitative composition of immediate release (IR) tablets containing these active substances with a Marketing Authorization (MA) in the Netherlands (NL) are also provided; in view of these MA’s th...

Literature and experimental data relevant to the decision to allow a waiver of in vivo bioequivalence testing for the approval of immediate release (IR) solid oral dosage forms containing ranitidine hydrochloride are reviewed. According to the current Biopharmaceutics Classification System (BCS), ranitidine hydrochloride should be assigned to Class III. However, based on its therapeutic and the...

The demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Biopharmaceutics Classification System (BCS) sets a scientific basis for an improved BE standard fo...