Taylor's Library

The pharmaceutical regulatory process (Record no. 145243)

000 -LEADER
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001 - CONTROL NUMBER
control field vtls003240872
003 - CONTROL NUMBER IDENTIFIER
control field MY-SjTCS
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20200508124542.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS
fixed length control field m d
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr cnu---unuuu
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 120913s2008 nyua sb 001 0 eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781420070439 (ebk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 1420070436 (ebk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9786611948726
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 6611948724
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Canceled/invalid ISBN 1420070428 (Cloth)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Canceled/invalid ISBN 9781420070422
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)312146716
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)ocn312146716
039 #9 - LEVEL OF BIBLIOGRAPHIC CONTROL AND CODING DETAIL [OBSOLETE]
Level of rules in bibliographic description 201209131004
Level of effort used to assign nonsubject heading access points shuhada
-- 201209131002
-- shuhada
043 ## - GEOGRAPHIC AREA CODE
Geographic area code n-us---
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 344.7304/233
Edition number 22
245 04 - TITLE STATEMENT
Title The pharmaceutical regulatory process
Medium [electronic resource] /
Statement of responsibility, etc. edited by Ira R. Berry, Robert P. Martin.
250 ## - EDITION STATEMENT
Edition statement 2nd ed.
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. New York :
Name of publisher, distributor, etc. Informa Healthcare,
Date of publication, distribution, etc. c2008.
300 ## - PHYSICAL DESCRIPTION
Extent 1 online resource (x, 469 p.) :
Other physical details ill.
490 1# - SERIES STATEMENT
Series statement Drugs and the pharmaceutical sciences ;
Volume/sequential designation 185
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note Includes bibliographical references and index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann -- Modernizing the Food And Drug Administration / Arthur Y. Tsien -- The new drug-approval process : before and after 1962 / Michael P. Peskoe -- Generic drug approval process : Hatch-Waxman Update / Marc S. Gross ... [et al.] -- FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd -- FDA's antibiotic regulatory scheme : then and now / Irving L. Wiesen -- Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.] -- The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Clinical research requirements for new drug applications / Gary L. Yingling and Ann M. Begley -- Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin -- Drugs marketed without FDA approval / Jane Baluss and David Rosen -- FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England -- Active pharmaceutical ingredients / Max S. Lazar -- Obtaining approval of New Drug Applications and Abbreviated New Drug Applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah -- Obtaining approval of a generic drug : pre- 1984 to the present / Loren Gelber -- New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Current good manufacturing practice and the drug approval process / Ira R. Berry -- The influence of the USP on the drug approval process / Edward M. Cohen -- Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo -- Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta -- CMC postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour -- Living with 21 CFR part 11 compliance / Richard L. Burcham.
588 ## - SOURCE OF DESCRIPTION NOTE
Source of description note Description based on print version record.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pharmacy
General subdivision Law and legislation
Geographic subdivision United States.
9 (RLIN) 21087
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Drugs
General subdivision Law and legislation
Geographic subdivision United States.
9 (RLIN) 21088
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Electronic books.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Berry, Ira R.,
Dates associated with a name 1942-
9 (RLIN) 21089
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Martin, Robert P.
Fuller form of name (Robert Paul)
9 (RLIN) 64571
776 08 - ADDITIONAL PHYSICAL FORM ENTRY
Relationship information Print version:
Title Pharmaceutical regulatory process.
Edition 2nd ed.
Place, publisher, and date of publication New York : Informa Healthcare, c2008
International Standard Book Number 9781420070422
-- 1420070428
Record control number (DLC) 2008042661
-- (OCoLC)259902129
830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE
Uniform title Drugs and the pharmaceutical sciences ;
Volume/sequential designation v. 185.
9 (RLIN) 21072
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier https://ezproxy.taylors.edu.my/login?url=http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=260345
Public note An electronic book accessible through the World Wide Web; click to view
999 ## - SYSTEM CONTROL NUMBERS (KOHA)
Koha biblionumber 145243
Koha biblioitemnumber 145243
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Permanent Location Current Location Date acquired Cost, normal purchase price Date last seen Price effective from Koha item type Public note
        e-book Taylor's Library-TU Taylor's Library - Perpetual(TU) 2020-02-20 799.84 2020-02-20 2020-02-20 Main Collection SOPxx,31001,03,RA,PPT
        e-book Taylor's Library-TU Taylor's Library - Perpetual(TU) 2020-02-20 799.84 2020-02-20 2020-02-20 Main Collection SOPxx,31001,03,RM,PPT