Generic drug product development
Subtitle: bioequivalence issues
By: [edited by]Isadore Kanfer, Leon Shargel.
Contributors: Kanfer, Isadore.; Shargel, Leon, 1941-
Series: Drugs and the pharmaceutical sciences -- 180
Publisher: Informa Healthcare
Published: 2008
Place of publication: New York
Language: eng
Number of pages: 264
ISBN-13: 9780849377846
Subjects: Drugs -- Therapeutic equivalency; Drugs -- Bioavailability; Generic drugs; Drugs, Generic; Biological Availability; Therapeutic Equivalency
Notes: Includes bibliographical references and index.
Table of contents: class: part
title: Introduction; class: part
title: bioequivalence issues / Isadore Kanfer and Leon Shargel; class: part
title: Approved drug products with therapeutic equivalence evaluations (the orange book) / Loren Gelber; class: part
title: Pharmaceutical alternatives : considerations for generic substitution / Roderick B. Walker, Roger K. Verbeeck, Isadore Kanfer; class: part
title: Pharmacodynamic measurements for determination of bioequivalence / Manish Issar, Jeffrey G. Stark, and Leon Shargel; class: part
title: Bioequivalence using clinical endpoint studies / Christopher Hendy; class: part
title: Evaluation of bioequivalence of highly variable drugs / Laszlo Endrenyi and Laszlo Tothfalusi; class: part
title: Statistical considerations: alternate designs and approaches for bioequivalence assessments / Stanford Bolton and Charles Bon; class: chapter
title: Population pharmokinetic approaches for assessing bioequivalence / Philippe Colucci, Jean-Francois Marier, and Murray P. Ducharme; class: part
title: Role of metabolites in bioequivalence assessent / André Jackson; class: part
title: Implications of chirality for the assessment of bioequivalence / Reza Mehvar and Fakhreddin Jamali; class: part
title: Effect of food on bioavailability and the assessment of bioequivalence / Kim Dalhoff and Isadore Kanfer; class: part
title: Bioequivalence assessment of endogenous drug substances: pharmacokinetics and statistical evaluation / Philippe Colucci ... [et al.].