Bibliographic Information

Pharmaceutical bioequivalence

edited by Peter G. Welling, Francis L.S. Tse, Shrikant V. Dighe

(Drugs and the pharmaceutical sciences, v. 48)

Dekker, c1991

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Note

Includes bibliographical references and index

Description and Table of Contents

Description

The rate and extent of drug absorption are a function of many factors, including the site of administration, the physiochemical characteristics of the compound, and the dosage form. The issues involved in bioequivalence and bioavailability are enmeshed in controversy, which is compounded by issues o

Table of Contents

"Bioequivalence and Its Determination Bioequivalence and Therepeutic Equivalence, Rober L. Williams Study Design for the Assessment of Bioavailability and Bioequivalence, Francis L. S. Tse, William T. Robinson, and Miles G. Choc Statistical Criteria, Carl M. Metzler Influence of Disease on Bioavailability, Wolfgang A. Ritschel and Donald D. Denson Factors Influencing Bioavailability and Bioequivalence, Arzu Selen The Role of Intestinal Metabolism on Bioavailability, William H. Barr Bioavailability of Transdermal and Topical Dosage Forms, Marvin C. Meyer In Vitro Methods to Determine Bioavailability: In Vitro-In Vivo Correlations, Peter G. Welling SPECIAL DIFFERENCES Pharmacodynamic Models Animal Models for Oral Drug Absorption, Jennifer B. Dressman and Kenji Yamada Interspecies Scaling in Pharmacokinetics, Patrick J. McNamara Pharmacodynamic Models in Bioequivalence, S. Thomas Forgue and Wayne A. Colburn Perspectives of Regulatory Agencies, Worldwide, on Bioequivalence Testing Bioequivalence: A United States Regulatory Perspective, Shrikant V. Dighe and Wallace P. Adams Bioequivalence: A Canadian Regulatory Perspective, Iain J. McGilveray Bioequivalence: A European Community Regulatory Perspective, A. G. Rauws Bioavailability and Bioequivalence: An Australian Perspective, Susan Walters and R. Rodney Charles Hall Bioequivalence: A Nordic Perspective, Tomas Salmonson, Hans Melander, and Anders Rane "

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