A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability

GL Amidon, H Lennernäs, VP Shah, JR Crison - Pharmaceutical research, 1995 - Springer
A biopharmaceutics drug classification scheme for correlating in vitro drug product dissolution
and in vivo bioavailability is proposed based on recognizing that drug dissolution and …

Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms

JB Dressman, GL Amidon, C Reppas, VP Shah - Pharmaceutical research, 1998 - Springer
Dissolution tests are used for many purposes in the pharmaceutical industry: in the
development of new products, for quality control and, to assist with the determination of …

A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain, and Japan

…, S Yamashita, LX Yu, GL Amidon - Molecular …, 2006 - ACS Publications
Orally administered, immediate-release (IR) drug products in the top 200 drug product lists
from the United States (US), Great Britain (GB), Spain (ES), and Japan (JP) were provisionally …

Estimating the fraction dose absorbed from suspensions of poorly soluble compounds in humans: a mathematical model

DM Oh, RL Curl, GL Amidon - Pharmaceutical research, 1993 - Springer
A microscopic mass balance approach has been developed to predict the fraction dose
absorbed of suspensions of poorly soluble compounds. The mathematical model includes four …

Gastrointestinal uptake of biodegradable microparticles: effect of particle size

MP Desai, V Labhasetwar, GL Amidon… - Pharmaceutical research, 1996 - Springer
Purpose. To investigate the effect of microparticle size on gastrointestinal tissue uptake.
Methods. Biodegradable microparticles of various sizes using polylactic polyglycolic acid (50:50) …

Modern bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards

R Löbenberg, GL Amidon - European journal of pharmaceutics and …, 2000 - Elsevier
In the last decade, the regulatory bioequivalence (BE) requirements of drug products have
undergone major changes. The introduction of the biopharmaceutics drug classification …

A compartmental absorption and transit model for estimating oral drug absorption

XY Lawrence, GL Amidon - International journal of pharmaceutics, 1999 - Elsevier
This report describes a compartmental absorption and transit model to estimate the fraction
of dose absorbed and the rate of drug absorption for passively transported drugs in …

The mechanism of uptake of biodegradable microparticles in Caco-2 cells is size dependent

…, V Labhasetwar, E Walter, RJ Levy, GL Amidon - Pharmaceutical …, 1997 - Springer
Purpose. To study the uptake of biodegradable microparticles in Caco-2 cells. Methods.
Biodegradable microparticles of polylactic polyglycolic acid co-polymer (PLGA 50:50) of mean …

Molecular properties of WHO essential drugs and provisional biopharmaceutical classification

…, KK Midha, VP Shah, GL Amidon - Molecular …, 2004 - ACS Publications
The purpose of this study is to provisionally classify, based on the Biopharmaceutics
Classification System (BCS), drugs in immediate-release dosage forms that appear on the World …

[PDF][PDF] Biopharmaceutics classification system: the scientific basis for biowaiver extensions

JE Polli, LX Yu, MU Mehta, GL Amidon, H Zhao… - 2002 - deepblue.lib.umich.edu
Since the introduction of the Biopharmaceutics Classification System (BCS)(1), its validity and
applicability have been the subject of extensive research and discussion (2). These efforts …