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
Antibody Drug Conjugates: Design and Selection of Linker, Payload and Conjugation Chemistry
Antibody drug conjugates (ADCs) have emerged as an important pharmaceutical class of drugs designed to harness the specificity of antibodies with the potency of small molecule therapeutics. The three main components of A...
Continuous Production of Fenofibrate Solid Lipid Nanoparticles by Hot-Melt Extrusion Technology: a Systematic Study Based on a Quality by Design Approach
The online version of this article (doi:10.1208/s12248-014-9674-8) contains supplementary material, which is available to authorized users.
Predicting when Biliary Excretion of Parent Drug is a Major Route of Elimination in Humans
The online version of this article (doi:10.1208/s12248-014-9636-1) contains supplementary material, which is available to authorized users.
PEITC Induces G1 Cell Cycle Arrest on HT-29 Cells Through the Activation of p38 MAPK Signaling Pathway
Phenethyl isothiocyanate (PEITC), an isothiocyanate abundantly found in cruciferous vegetables have been shown to induce apoptosis through MAPK pathway in prostate and colon cancer cells. In the present study, we investi...
Prediction-Corrected Visual Predictive Checks for Diagnosing Nonlinear Mixed-Effects Models
The online version of this article (doi:10.1208/s12248-011-9255-z) contains supplementary material, which is available to authorized users.