Generic drug product development : (Record no. 57998)

MARC details
000 -LEADER
fixed length control field 03057nam\a2200385\a\4500
001 - CONTROL NUMBER
control field 57998
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20260819122702.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 260819s2014 flua b 001 0 eng
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9781420086355
Qualifying information hbk. : alk. paper
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9781420086362
Qualifying information eBook
035 ## - SYSTEM CONTROL NUMBER
System control number (DNLM)101606012
040 ## - CATALOGING SOURCE
Original cataloging agency DNLM/DLC
Transcribing agency DLC
Modifying agency BD-DhIUB
082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.19
Edition number 23
Item number G3261
245 00 - TITLE STATEMENT
Title Generic drug product development :
Remainder of title solid oral dosage forms /
Statement of responsibility, etc edited by Leon Shargel, Isadore Kanfer.
250 ## - EDITION STATEMENT
Edition statement 2nd ed.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc Boca Raton, FL :
Name of publisher, distributor, etc CRC Press/Taylor & Francis Group,
Date of publication, distribution, etc c2014. (reprint 2024)
300 ## - PHYSICAL DESCRIPTION
Extent xii, 385 p. :
Other physical details ill. ;
Dimensions 25 cm.
490 0# - SERIES STATEMENT
Series statement Drugs and the pharmaceutical sciences ;
Volume number/sequential designation 129
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Active pharmaceutical ingredient / Edward M. Cohen, Steven Sutherland -- Analytical methods development and methods validation for solid oral dosage forms / Quanyin Gao, Dilip R. Sanvordeker -- Experimental formulation development / Isadore Kanfer ... [et al.] -- Scale-up, technology transfer, and process performance qualification / Salah U. Ahmed ... [et al.] -- Drug stability / Pranab K. Bhattacharyya -- Quality control and quality assurance / Loren Gelber -- Drug product performance, in vitro / Pradeep M. Sathe, John Duan, and Lawrence X. Yu -- ANDA regulatory approval process / Timothy W. Ames, Aaron Sigler -- Bioequivalence and drug product assessment, in vivo / Barbara M. Davit, Dale P, Conner -- Statistical considerations for establishing bioequivalence / Charles Bon, Sanford Bolton -- Outsourcing bioavailability and bioequivalence studies to contract research organizations / Patrick K. Noonan -- Post-approval changes and post-marketing surveillance / Lorien Armour, Leon Shargel -- United States Pharmacopeia-National Formulary : its history, organization, and role in harmonization / William Brown, Margareth R.C. Marques -- Legal and legislative hurdles to generic drug development, approval and marketing / Arthur T. Tsien.
520 ## - SUMMARY, ETC.
Summary, etc "This book collects in-depth discussions from more than 30 noted specialists on topics such as quality control, experimental formulations, pharmaceutical ingredients, conventional and modified-release products, and bioequivalence. It considers key elements in the formulation of generic drug products including the availability of raw materials and chemical purity. It contains new chapters on experimental formulation development, and the relationship between the FDA and the United States Pharmacopeia"--Provided by publisher.
526 ## - STUDY PROGRAM INFORMATION NOTE
School name Pharmacy
Department Pharmacy
Shelving Location Pharmacy Corner
541 ## - IMMEDIATE SOURCE OF ACQUISITION NOTE
Source of acquisition law
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Generic drugs.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Solid dosage forms.
650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drugs, Generic
General subdivision standards.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Chemistry, Pharmaceutical
General subdivision standards.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Drug Approval.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name as entry element Tablets.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Shargel, Leon,
Dates associated with a name 1941-
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Kanfer, Isadore.
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Dewey Decimal Classification
Koha item type Books
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Home library Current library Shelving location Date acquired Source of acquisition Cost, normal purchase price Serial Enumeration / chronology Total Checkouts Full call number Barcode Date last seen Copy number Cost, replacement price Price effective from Koha item type
    Dewey Decimal Classification   Not For Loan Library, Independent University, Bangladesh (IUB) Library, Independent University, Bangladesh (IUB) Pharmacy Corner 13/08/2026 Purchase 5199.00 20174   615.19 G3261 030012 19/08/2026 01 10398.00 13/08/2026 Books
    Dewey Decimal Classification   Not For Loan Library, Independent University, Bangladesh (IUB) Library, Independent University, Bangladesh (IUB) Pharmacy Corner 13/08/2026 Purchase 5199.00 20174   615.19 G3261 030013 19/08/2026 02 10398.00 13/08/2026 Books