عنوان
پدید آورنده
موضوع
رده
RM301.45 .G42 2008
RM301
.
45
.
G42
2008
کتابخانه
محل استقرار
INTERNATIONAL STANDARD BOOK NUMBER
(Number (ISBN
0849377846 (hardcover : alk. paper)
(Number (ISBN
9780849377846 (hardcover : alk. paper)
NATIONAL BIBLIOGRAPHY NUMBER
Number
b428943
TITLE AND STATEMENT OF RESPONSIBILITY
Title Proper
Generic drug product development :
General Material Designation
[Book]
Other Title Information
bioequivalence issues /
First Statement of Responsibility
[edited by]Isadore Kanfer, Leon Shargel
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
New York :
Name of Publisher, Distributor, etc.
Informa Healthcare,
Date of Publication, Distribution, etc.
c2008
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
x, 264 p. :
Other Physical Details
ill. ;
Dimensions
24 cm
SERIES
Series Title
Drugs and the pharmaceutical sciences ;
ISSN of Series
180
INTERNAL BIBLIOGRAPHIES/INDEXES NOTE
Text of Note
Includes bibliographical references and index
CONTENTS NOTE
Text of Note
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 --
Text of Note
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 ... [et al.]
Text of Note
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 --
Text of Note
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 --
0
0
0
0
TOPICAL NAME USED AS SUBJECT
Drugs-- Bioavailability
Drugs-- Therapeutic equivalency
Generic drugs
Biological Availability
Drugs, Generic
Therapeutic Equivalency
DEWEY DECIMAL CLASSIFICATION
Number
615/
.
1
Edition
22
LIBRARY OF CONGRESS CLASSIFICATION
Class number
RM301
.
45
Book number
.
G42
2008
OTHER CLASS NUMBERS
Class number
QV
38
Class number
W1
Book Number
G3255
2008
Book Number
DR893B
v
.
180
2008
PERSONAL NAME - ALTERNATIVE RESPONSIBILITY
Kanfer, Isadore
Shargel, Leon,1941-
ORIGINATING SOURCE
Date of Transaction
20080418033204.0
ELECTRONIC LOCATION AND ACCESS
Electronic name
مطالعه متن کتاب [Book]
Y
