http://hdl.handle.net/10451/3727 2013-05-24T19:39:52Z 2013-05-24T19:39:52Z Karalis, Vangelis Magklara, Eleni Shah, Vinod P. Macheras, Panos Morais, José A. http://hdl.handle.net/10451/8212 2013-04-04T14:39:42Z 2010-09-01T00:00:00Z

Title: From Drug Delivery Systems to Drug Release, Dissolution, IVIVC, BCS, BDDCS, Bioequivalence and Biowaivers Authors: Karalis, Vangelis; Magklara, Eleni; Shah, Vinod P.; Macheras, Panos; Morais, José A. Abstract: This is a summary report of the conference on drug absorption and bioequivalence issues held in Titania Hotel in Athens (Greece) from the 28(th) to the 30(th) of May 2009. The conference included presentations which were mainly divided into three sections. The first section focused on modern drug delivery systems such as polymer nanotechnology, cell immobilization techniques to deliver drugs into the brain, nanosized liposomes used in drug eluting stents, encapsulation of drug implants in biocompatible polymers, and application of differential scanning calorimetry as a tool to study liposomal stability. The importance of drug release and dissolution were also discussed by placing special emphasis on camptothecins and oral prolonged release formulations. The complexity of the luminal environment and the value of dissolution in lyophilized products were also highlighted. The second session of the conference included presentations on the Biopharmaceutics Classification Scheme (BCS), the Biopharmaceutics Drug Disposition Classification System (BDDCS), and the role of transporters in the classification of drugs. The current status of biowaivers and a modern view on non-linear in vitro-in vivo (IVIVC) correlations were also addressed. Finally, this section ended with a special topic on biorelevant dissolution media and methods. The third day of the conference was dedicated to bioequivalence. Emphasis was placed on high within-subject variability and its impact on study design. Two unresolved issues of bioequivalence were also discussed: the use of generic antiepileptic drugs and the role of metabolites in bioequivalence assessment. Finally, the conference closed with a presentation of the current regulatory status of WHO and EMEA.

2010-09-01T00:00:00Z Chen, Mei-Ling Shah, Vinod P. Crommelin, Daan J. Shargel, Leon Bashaw, Dennis Bhatti, Masood Blume, Henning Dressman, Jennifer Ducharme, Murray Fackler, Paul Hyslop, Terry Lutter, Lorelei Morais, José A.G. Ormsby, Eric Thomas, Saji Tsang, Yu Chung Velagapudi, Raja Yu, Lawrence X. http://hdl.handle.net/10451/8159 2013-04-02T14:25:39Z 2011-11-20T00:00:00Z

Title: Harmonization of Regulatory Approaches for Evaluating Therapeutic Equivalence and Interchangeability of Multisource Drug Products: Workshop Summary Report Authors: Chen, Mei-Ling; Shah, Vinod P.; Crommelin, Daan J.; Shargel, Leon; Bashaw, Dennis; Bhatti, Masood; Blume, Henning; Dressman, Jennifer; Ducharme, Murray; Fackler, Paul; Hyslop, Terry; Lutter, Lorelei; Morais, José A.G.; Ormsby, Eric; Thomas, Saji; Tsang, Yu Chung; Velagapudi, Raja; Yu, Lawrence X. Abstract: Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.

2011-11-20T00:00:00Z