The pharmaceutical regulatory process / (Record no. 5241)

000 -LEADER
fixed length control field 03503cam a2200349 a 4500
001 - CONTROL NUMBER
EWU control number 5241
003 - CONTROL NUMBER IDENTIFIER
control field BD-DhEWU
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20190310095357.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 050107s2005 nyua g b 001 0 eng d
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
LC control number 2005041971
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 0824754646 (alk. paper)
International Standard Book Number 9780824754648
035 ## - SYSTEM CONTROL NUMBER
OCLC control number (OCoLC)57434176
040 ## - CATALOGING SOURCE
Original cataloging agency DLC
Transcribing agency DLC
Modifying agency DLC
-- BD-DhEWU
Language of cataloging eng
041 ## - LANGUAGE CODE
Language code of text/sound track or separate title eng
050 00 - LIBRARY OF CONGRESS CALL NUMBER
Classification number KF2036.D7
Item number P47 2005
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.173
Author mark and Year PHA 2005
245 04 - TITLE STATEMENT
Title The pharmaceutical regulatory process /
Statement of responsibility, etc edited by Ira R. Berry.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc New York ;
-- Dhaka :
Name of publisher, distributor, etc Marcel Dekker ;
-- Bangladesh Photostat,
Date of publication, distribution, etc 2005.
300 ## - PHYSICAL DESCRIPTION
Extent xiii, 711 p. :
Other physical details ill. ;
Dimensions 25 cm.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
505 ## - FORMATTED CONTENTS NOTE
Title Table of contents
Contents note Pharmaceutical regulation before and after the food, drug, and cosmetic act / John P. Swann --<br/>The new drug-approval process-before and after 1962 / Michael P. Peskoe --<br/>FDA regulation of biological products / James N. Czaban and Natasha Leskovsek --<br/>Generic drug approval process: pre-1984 history concerning generic drugs / David L. Rosen --<br/>Generic drug approval process, post-1984: Hatch-Waxman reform / Marc S. Gross ...[et al.] --<br/>Food and drug administration modernization act / Arthur Y. Tsien and Patricia E. Pahl --<br/>FDA Antibiotic regulatory scheme: then and now / Irving L. Wiesen --<br/>Pioneer and generic drugs: balance between product life cycle extension and anticompetitive behavior / Robert G. Pinco and Barbara A. Binzak --<br/>The influence of the prescription drug user fee act on the approval process / Marc J. Scheineson --<br/>Clinical research requirements for new drug applications / Gary Yingling and Ann Begly --<br/>Active pharmaceutical ingredients / Max S. Lazar --<br/>Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah --<br/>Obtaining approval of a generic drug / Loren Gelber --<br/>Current good manufacturing practice and the drug approval process / Nicholas Buhay --<br/>CMC post-approval regulatory affairs: constantly managing change / Leo J. Lucisano and Kevin A. Miller --<br/>The influence of the USP on the drug approval process / Edward M. Cohen --<br/>Ways and means to U.S. registration of foreign drugs / Alberto Grignolo ...[et al.] --<br/>Common techinical document-quality (M4-Q): one regulatory participant's perspective / Ubrani V. Venkataram --<br/>21 CFR part 11 compliance and beyond / Richard L. Burcham --<br/>Marketing and advertising/promotion: the impact of government regulations / Daniel Glassman, Philip W. McGinn, Jr., and Gene Goldberg --<br/>Approval and marketing of nonprescription or OTC human drugs / William J. Mead.
520 ## - SUMMARY, ETC.
Summary, etc Summary:<br/>A tool to navigate and understand the pharmaceutical regulatory framework. Covering the procedures utilized by pharmaceutical companies for regulatory compliance, this book describes the history and development of regulations, standards, and guidelines that affect pharmaceutical product approval and commercial sale in the United States.
526 ## - STUDY PROGRAM INFORMATION NOTE
Program name Pharmacy
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name Pharmacy
General subdivision Law and legislation
Geographic subdivision United States.
9 (RLIN) 8533
Topical term or geographic name Drugs
General subdivision Law and legislation
Geographic subdivision United States.
9 (RLIN) 8534
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Berry, Ira R.
9 (RLIN) 8535
856 42 - ELECTRONIC LOCATION AND ACCESS
Materials Specified WorldCat details
Uniform Resource Identifier http://www.worldcat.org/title/pharmaceutical-regulatory-process/oclc/57434176&referer=brief_results
Materials Specified Ebook Fulltext
Uniform Resource Identifier http://lib.ewubd.edu/ebook/5241
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme
Koha item type Text
Holdings
Lost status Source of classification or shelving scheme Not for loan Collection code Permanent Location Current Location Shelving location Date of accession Source of acquisition Cost, normal purchase price Full call number Barcode Copy number Koha item type Total Checkouts Total Renewals Date last seen Date checked out Price effective from
    Not For Loan Non-fiction EWU Library EWU Library Reserve Section 2007-01-21 Karim International 12100.00 615.173 PHA 2005 19541 C-1 Text          
      Non-fiction EWU Library EWU Library Circulation Section 2007-01-21 Bangaldesh Photostat 946.00 615.173 PHA 2005 19542 C-2 Text          
      Non-fiction EWU Library EWU Library Circulation Section 2007-01-21 Bangaldesh Photostat 946.00 615.173 PHA 2005 19543 C-3 Text          
      Non-fiction EWU Library EWU Library Circulation Section 2007-01-21 Bangaldesh Photostat 946.00 615.173 PHA 2005 19544 C-4 Text          
      Non-fiction EWU Library EWU Library Circulation Section 2007-01-21 Bangaldesh Photostat 946.00 615.173 PHA 2005 19545 C-5 Text 2 1 2017-05-24 2015-07-07  
      Non-fiction EWU Library EWU Library E-book 2018-01-09     615.173 PHA 2005     E-Book     2018-01-09   2018-01-09

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