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 |