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FDA regulatory affairs : (Record no. 266991)

MARC details
000 -LEADER
fixed length control field 03982cam a2200589Mi 4500
001 - CONTROL NUMBER
control field ocn872703723
003 - CONTROL NUMBER IDENTIFIER
control field OCoLC
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20210921181052.0
006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS
fixed length control field m o d
007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION
fixed length control field cr |n|||||||||
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 140224s2014 flua |ob 001|0 eng d
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781841849201
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781841849201
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 1841849200
Qualifying information (electronic bk.)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Canceled/invalid ISBN 9781841849195
Qualifying information (hardcover ;
-- alk. paper)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
Canceled/invalid ISBN 1841849197
Qualifying information (hardcover ;
-- alk. paper)
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC)
OCLC library identifier NZ1
System control number 15585832
029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC)
OCLC library identifier GBVCP
System control number 777722348
035 ## - SYSTEM CONTROL NUMBER
System control number (OCoLC)872703723
Canceled/invalid control number (OCoLC)869639807
-- (OCoLC)960113896
-- (OCoLC)985182367
040 ## - CATALOGING SOURCE
Original cataloging agency CNSPO
Language of cataloging eng
Description conventions pn
Transcribing agency CNSPO
Modifying agency OCLCO
-- OCLCF
-- OCLCO
-- AZU
-- YDXCP
-- OCLCA
-- UIU
-- CRCPR
-- OCLCQ
-- EBLCP
-- E7B
-- OCLCQ
-- CAUOI
-- OCLCQ
-- OCLCO
-- OCLCA
-- YDX
-- OCLCO
-- OCLCQ
-- OCLCA
-- MERUC
-- OCLCO
-- OCLCA
043 ## - GEOGRAPHIC AREA CODE
Geographic area code n-us---
245 10 - TITLE STATEMENT
Title FDA regulatory affairs :
Remainder of title [electronic book] /
250 ## - EDITION STATEMENT
Edition statement 3rd edition.
264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Place of production, publication, distribution, manufacture Boca Raton, Florida :
Name of producer, publisher, distributor, manufacturer CRC Press,
Date of production, publication, distribution, manufacture, or copyright notice 2014.
300 ## - PHYSICAL DESCRIPTION
Extent 1 online resource (xii, 387 pages).
336 ## - CONTENT TYPE
Content type term text
Content type code txt
Source rdacontent
336 ## - CONTENT TYPE
Content type term text
Source rdacontent
337 ## - MEDIA TYPE
Media type term computer
Media type code c
Source rdamedia
337 ## - MEDIA TYPE
Media type term computer
Source rdamedia
338 ## - CARRIER TYPE
Carrier type term online resource
Carrier type code cr
Source rdacarrier
338 ## - CARRIER TYPE
Carrier type term online resource
Source rdacarrier
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc. note Includes bibliographical references and index.
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Overview of FDA and drug development / Josephine C. Babiarz and Douglas Pisano -- What is an IND? / Michael R. Hamrell -- The new drug application / Charles Monahan and Josephine C. Babiarz -- Meetings with the FDA / Alberto Grignolo and Sally Choe -- FDA medical device regulation / Barry Sall -- A primer of drug/device law : what is the law and how do I find it? / Josephine C. Babiarz -- The development of orphan drugs / Scott N. Freeman -- CMC sections of regulatory filings and CMC regulatory -- Compliance during investigational and postapproval stages / Prabu Nambiar, Steven R. Koepke, and Kevin Swiss -- Overview of the gxps for the regulatory professional / Bob Buckley, Robert Blanks, Kimberly J. White, and Tonya White-Salters -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- The practice of regulatory affairs / David S. Mantus -- FDA advisory / Christina A. McCarthy and David S. Mantus -- Biologics / Florence Kaltovich -- Regulation of combination products in the United States / John Barlow Weiner.
520 8# - SUMMARY, ETC.
Summary, etc. This third edition of 'FDA Regulatory Affairs' examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. Focusing on new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements this is a key title for anyone involved in pharmaceutical regulation. Jargon-free and drawing information from a wide range of resources, this book demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval.
610 10 - SUBJECT ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element United States.
Subordinate unit Food and Drug Administration
Form subdivision Rules and practice.
610 12 - SUBJECT ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element United States
Subordinate unit Food and Drug Administration.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Drug development.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Drug development
Geographic subdivision United States.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pharmaceutical industry
Geographic subdivision United States.
650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element United States Government Agencies.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Biological Factors
General subdivision standards.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Equipment and Supplies
General subdivision standards.
650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Government Regulation.
651 #2 - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Geographic name United States.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Mantus, David,
Relator term editor.
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Pisano, Douglas J.,
Relator term editor.
710 ## - ADDED ENTRY--CORPORATE NAME
Corporate name or jurisdiction name as entry element EBSCO
Relator term vendor
856 40 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier <a href="http://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,sso&db=nlebk&AN=686544&site=ehost-live&custid=s7813921">http://search.ebscohost.com/login.aspx?direct=true&AuthType=ip,sso&db=nlebk&AN=686544&site=ehost-live&custid=s7813921</a>
Public note Access ebook here
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme Dewey Decimal Classification
Koha item type EBSCO Ebook
Suppress in OPAC 0
948 ## - LOCAL PROCESSING INFORMATION (OCLC); SERIES PART DESIGNATOR (RLIN)
h (OCLC) NO HOLDINGS IN LQI - 61 OTHER HOLDINGS
998 ## - LOCAL CONTROL INFORMATION (RLIN)
Local n
Holdings
Withdrawn status Lost status Source of classification or shelving scheme Damaged status Not for loan Home library Current library Shelving location Date acquired Cost, normal purchase price Total Checkouts Date last seen Price effective from Koha item type
    Dewey Decimal Classification   Available Online ATU Sligo Yeats Library ATU Sligo Yeats Library eBook 27/09/2018 185.08   27/09/2018 27/09/2018 Ebook