The Resource Generic drug product development : bioequivalence issues, [edited by]Isadore Kanfer, Leon Shargel

Generic drug product development : bioequivalence issues, [edited by]Isadore Kanfer, Leon Shargel

Label
Generic drug product development : bioequivalence issues
Title
Generic drug product development
Title remainder
bioequivalence issues
Statement of responsibility
[edited by]Isadore Kanfer, Leon Shargel
Contributor
Subject
Language
eng
Summary
The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be consid
Member of
Action
digitized
Cataloging source
OCLCE
Dewey number
615/.1
Illustrations
illustrations
Index
index present
LC call number
RM301.45
LC item number
.G42 2008
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Series statement
Drugs and the pharmaceutical sciences
Series volume
180
Label
Generic drug product development : bioequivalence issues, [edited by]Isadore Kanfer, Leon Shargel
Publication
Antecedent source
file reproduced from original
Bibliography note
Includes bibliographical references and index
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
black and white
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
  • Bioequivalence using clinical endpoint studies / Christopher Hendy -- Evaluation of bioequivalence of highly variable drugs / Laszlo Endrenyi and Laszlo Tothfalusi -- Statistical considerations: alternate designs and approaches for bioequivalence assessments / Stanford Bolton and Charles Bon
  • Effect of food on bioavailability and the assessment of bioequivalence / Kim Dalhoff and Isadore Kanfer -- Bioequivalence assessment of endogenous drug substances: pharmacokinetics and statistical evaluation / Philippe Colucci [and others]
  • Introduction-- bioequivalence issues / Isadore Kanfer and Leon Shargel -- Approved drug products with therapeutic equivalence evaluations (the orange book) / Loren Gelber -- Pharmaceutical alternatives : considerations for generic substitution / Roderick B. Walker, Roger K. Verbeeck, Isadore Kanfer -- Pharmacodynamic measurements for determination of bioequivalence / Manish Issar, Jeffrey G. Stark, and Leon Shargel
  • Population pharmokinetic approaches for assessing bioequivalence / Philippe Colucci, Jean-Francois Marier, and Murray P. Ducharme -- Role of metabolites in bioequivalence assessent / André Jackson -- Implications of chirality for the assessment of bioequivalence / Reza Mehvar and Fakhreddin Jamali
Control code
ocn608629706
Dimensions
unknown
Extent
1 online resource (x, 264 pages)
File format
one file format
Form of item
online
Isbn
9781420020014
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations
http://library.link/vocab/recordID
.b24473868
Reproduction note
Electronic reproduction.
Specific material designation
remote
System control number
  • (OCoLC)608629706
  • pebco1420020013
System details
Master and use copy. Digital master created according to Benchmark for Faithful Digital Reproductions of Monographs and Serials, Version 1. Digital Library Federation, December 2002.

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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