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
Procedural elements involved in maintaining bioanalytical data integrity for good laboratory practices studies and regulated clinical studies
This article describes procedural elements involved in ensuring the integrity of bioanalytical data. These elements can be divided into 3 areas. First, there are those ensuring the integrity of the analyte until analysis...
Squarticles as a Lipid Nanocarrier for Delivering Diphencyprone and Minoxidil to Hair Follicles and Human Dermal Papilla Cells
Delivery of diphencyprone (DPCP) and minoxidil to hair follicles and related cells is important in the treatment of alopecia. Here we report the development of “squarticles,” nanoparticles formed from seb...
Pharmacokinetic-pharmacodynamic modeling in the data analysis and interpretation of drug-induced QT/QTc prolongation
In this review, factors affecting the QT interval and the methods that are currently in use in the analysis of drug effects on the QT interval duration are overviewed with the emphasis on (population) pharmacokinetic-pha...
Evaluation of sucrose esters as alternative surfactants in microencapsulation of proteins by the solvent evaporation method
Sucrose esters (SE) are surfactants with potential pharmaceutical applications because of their low toxicity, biocompatibility, and excellent biodegradability. The objective of the study was to investigate SE as alternat...
Biopharmaceutic Planning in Pediatric Drug Development
Pediatric drug development is a required consideration for all drug development programs. Age-appropriate formulations such as suspensions, chewable tablets, oral disintegrating tablets, etc., are typically developed and...