Oral Drug Absorption: Prediction and Assessment, Second Edition, 2nd Edition (Hardback) book cover

Oral Drug Absorption

Prediction and Assessment, Second Edition, 2nd Edition

Edited by Jennifer B. Dressman, Christos Reppas

CRC Press

450 pages | 80 B/W Illus.

Purchasing Options:$ = USD
Hardback: 9781420077339
pub: 2010-03-25
$175.00
x
eBook (VitalSource) : 9780429147715
pub: 2016-04-19
from $28.98


FREE Standard Shipping!

Description

Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR and IR formulations.

This practical, hands-on guide includes an interactive CD-ROM that helps pharmaceutical industry personnel model their own testing data. They will learn how to identify formulations that will produce the best clinical results and verify batch-to-batch reproducibility. They will also understand how to identify whether changes in formulation or manufacturing procedure after marketing approval affect clinical performance, and how to determine if a generic version of the medicine can be approved

This edition includes information about bioequivalence studies, biowaiving, formulation screening, and different approaches from U.S. industry and European industry perspectives. It also reviews major advances in pharmacokinetic modeling and profiling. Case-based examples are included to clarify the material.

Table of Contents

Physiology of Oral Drug Absorption

Physiological Factors Affecting Drug Release and Absorption in the Gastrointestinal Tract

Erik Soderlind and Jennifer B. Dressman

Drug Transport Mechanisms Across the Intestinal Epithelium

Anna-Lena B. Ungell

Gastrointestinal Transit and Drug Absorption

Clive G. Wilson, Werner Weitschies, and James Butler

Gut Wall Metabolism

Mary F. Paine

Food Effects on Drug Absorption and Dosage Form Performance

Anette Mullertz

Oral Drug Absorption in Pediatric Populations

Andrea N. Edginton and Nikoletta Fotaki

Gastrointestinal Disease and Dosage Form Performance

Vladan Milovic and Ju¨rgen Stein

The Biopharmaceutics Classification System

The Biopharmaceutics Classification System: Recent Applications in Pharmaceutical Discovery, Development, and Regulation

Jennifer J. Sheng and Gordon L. Amidon

Drug Solubility in the Gastrointestinal Tract

Christos Reppas and Patrick Augustijns

Permeability Measurement

Joachim Brouwers, Sven Deferme, Pieter Annaert, and Patrick Augustijns

BCS: Today and Tomorrow

James E. Polli

Nonclinical Methods to Evaluate Oral Formulations

Dissolution Testing to Forecast In Vivo Performance of Immediate-Release Formulations

Ekarat Jantratid and Maria Vertzoni

Dissolution Testing to Forecast the In Vivo Performance of MR Formulations

Sandra Klein

Modified-Release Dosage Forms: Formulation Screening in the Pharmaceutical Industry

Bertil Abrahamsson and Erik So¨derlind

Immediate Release Oral Dosage Forms: Formulation Screening in the Pharmaceutical Industry

Yunhui Wu and Filippos Kesisoglou

Computer Models for Predicting Drug Absorption

Neil Parrott and Thierry Lave

Bioequivalence Studies

In Vivo Bioequivalence Assessment

Panos Macheras and Mira Symillides

Biowaiving Based on the BCS—A Global Comparison

Henrike Potthast

Biowaiving Based on In Vitro-In Vivo Correlation

Vinod P. Shah

About the Series

Drugs and the Pharmaceutical Sciences

Learn more…

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
MED072000
MEDICAL / Pharmacy