G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability, Pharm Res 12, 413–420, 1995—Backstory of BCS
Journal Title: The AAPS Journal - Year 2014, Vol 16, Issue 5
Abstract
The Biopharmaceutics Classification System (BCS) has become widely accepted today in the academic, industrial, and regulatory world. While the initial application of the BCS was to regulatory science bioequivalence (BE) issues and related implications, it has come to be utilized widely by the pharmaceutical industry in drug discovery and development as well. This brief manuscript will relate the story of the BCS development. While much of the ground work for the BCS goes back to the pharmacokinetic and drug absorption research by Gordon Amidon (GLA) in the 1970s and 1980s, the realization of the need for a classification or categorization of drug and drug products for setting dissolution standards became apparent to GLA during his 1990–1991 sabbatical year at the FDA. Initiated at the invitation of the then CEDR director, Dr. Carl Peck, to become a visiting scientist at the FDA, the goal was to promote regulatory research at the FDA, in my case, in biopharmaceutics, and to develop a science-based system to simplify regulatory requirements.
Authors and Affiliations
Vinod P. Shah, Gordon L. Amidon
Keywords
Related Articles
- EP ID EP681658
- DOI 10.1208/s12248-014-9620-9
- Views 67
- Downloads 0
Development of a Physiologically Based Pharmacokinetic Model to Predict Disease-Mediated Therapeutic Protein–Drug Interactions: Modulation of Multiple Cytochrome P450 Enzymes by Interleukin-6
Disease-mediated therapeutic protein–drug interactions have recently gained attention from regulatory agencies and pharmaceutical industries in the development of new biological products. In this study, we develo...
A Step-wise Approach for Transfer of Immunogenicity Assays during Clinical Drug Development
We designed a three-step statistical approach to transfer bioanalytical assays (ELISA and Biacore) which evaluates the (1) average equivalence between the two labs (2) concordance in individual sample results between the...
Model system to study classical nuclear export signals
Signal-mediated protein transport through the nuclear pore complex is of considerable interest in the field of molecular pharmaceutics. Nuclear localization signals can be used to target genes/antisense delivery systems...
Editorial: A New Series of Commentaries Entitled “Landmark Publications in the Pharmaceutical Sciences: The Backstory”
Pilot Investigation on Long-Term Subcutaneous Microdialysis: Proof of Principle in Humans
Reliable drug concentration measurements at the target site are increasingly demanded and can be achieved by microdialysis. The aim of this pilot study was to demonstrate the proof of principle of long-term subcutaneous...