Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond
Journal Title: The AAPS Journal - Year 2008, Vol 10, Issue 2
Abstract
The workshop “Bioequivalence, Biopharmaceutics Classification System, and Beyond” was held May 21–23, 2007 in North Bethesda, MD, USA. This workshop provided an opportunity for pharmaceutical scientists to discuss the FDA guidance on the Biopharmaceutics Classification System (BCS), bioequivalence of oral products, and related FDA initiatives such as the FDA Critical Path Initiative. The objective of this Summary Workshop Report is to document the main points from this workshop. Key highlights of the workshop were (a) the described granting of over a dozen BCS-based biowaivers by the FDA for Class I drugs whose formulations exhibit rapid dissolution, (b) continued scientific support for biowaivers for Class III compounds whose formulations exhibit very rapid dissolution, (c) scientific support for a number of permeability methodologies to assess BCS permeability class, (d) utilization of BCS in pharmaceutical research and development, and (e) scientific progress in in vitro dissolution methods to predict dosage form performance.
Authors and Affiliations
James E. Polli, Bertil S. I. Abrahamsson, Lawrence X. Yu, Gordon L. Amidon, John M. Baldoni, Jack A. Cook, Paul Fackler, Kerry Hartauer, Gordon Johnston, Steve L. Krill, Robert A. Lipper, Waseem A. Malick, Vinod P. Shah, Duxin Sun, Helen N. Winkle, Yunhui Wu, Hua Zhang
Nonclinical Dose Formulation: Out of Specification Investigations
Nonclinical safety studies are required to follow applicable Good Laboratory Practice (GLP) regulations. Nonclinical dose formulations are required to be analyzed to confirm the analyte concentration, homogeneity, and st...
Drug discovery from natural sources
Organic compounds from terrestrial and marine organisms have extensive past and present use in the treatment of many diseases and serve as compounds of interest both in their natural form and as templates for synthetic m...
Physiologically Based Pharmacokinetic Model of Amphotericin B Disposition in Rats Following Administration of Deoxycholate Formulation (Fungizone®): Pooled Analysis of Published Data
The time course of tissue distribution of amphotericin B (AmB) has not been sufficiently characterized despite its therapeutic importance and an apparent disconnect between plasma pharmacokinetics and clinical outcomes....
Design and synthesis of the CB1 selective cannabinoid antagonist AM281: A potential human SPECT ligand
In the search for a radioligand capable of imaging cannabinoid CB1 receptors in the living human brain by SPECT (single photon emission computed tomography), N-(morpholin-4-yl)-1-(2,4-dichlorophenyl)-5-(4-iodophenyl)-4-m...
Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9
The online version of this article (doi:10.1208/s12248-015-9750-8) contains supplementary material, which is available to authorized users.