MARC details
| 000 -LEADER |
|---|
| fixed length control field |
05277cam a2200565 i 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20250919005553.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
151007t20152015flua b 001 0 eng |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781439874202 (hardback : acid-free paper) |
| Terms of availability |
RM601.92 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
1439874204 (hardback : acid-free paper) |
| 039 #9 - LEVEL OF BIBLIOGRAPHIC CONTROL AND CODING DETAIL [OBSOLETE] |
|---|
| Level of rules in bibliographic description |
201510201236 |
| Level of effort used to assign nonsubject heading access points |
zainol |
| y |
10-07-2015 |
| z |
fida |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DLC |
| Language of cataloging |
eng |
| Description conventions |
rda |
| Transcribing agency |
DLC |
| Modifying agency |
YDX |
| -- |
BTCTA |
| -- |
YDXCP |
| -- |
UKMGB |
| -- |
IXA |
| -- |
NLM |
| -- |
ZWZ |
| -- |
OCLCF |
| -- |
CDX |
| -- |
BDX |
| -- |
CRCPR |
| 040 ## - CATALOGING SOURCE |
|---|
| Modifying agency |
UKM |
| Description conventions |
rda |
| 090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (RLIN) |
|---|
| Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) |
QU550.5.M8P536 2015 9 |
| 090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (RLIN) |
|---|
| Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) |
QU550.5.M8 |
| Local cutter number (OCLC) ; Book number/undivided call number, CALL (RLIN) |
P536 2015 9 |
| 245 00 - TITLE STATEMENT |
|---|
| Title |
Pharmaceutical industry practices on genotoxic impurities / |
| Statement of responsibility, etc. |
edited by Heewon Lee, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, USA. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
Boca Raton : |
| Name of producer, publisher, distributor, manufacturer |
CRC Press, Taylor & Francis Group, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2015 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xviii, 517 pages : |
| Other physical details |
illustrations ; |
| Dimensions |
24 cm. |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
text |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
unmediated |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
volume |
| Source |
rdacarrier |
| 490 1# - SERIES STATEMENT |
|---|
| Series statement |
Chromatographic science series ; |
| Volume/sequential designation |
107 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc. note |
Includes bibliographical references and index. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
'A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text:Explores the safety, quality, and regulatory aspects of GTIsProvides an overview of the latest FDA and EMEA guidelinesExplains the how and why of various GTI control tactics and practicesDescribes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testingIncludes real-life examples of GTI control in drug substance and drug product development processesContaining case studies from large and small pharmaceutical firms in multiple geographical regions, Pharmaceutical Industry Practices on Genotoxic Impurities supplies an overview of and a current framework for GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines'-- |
| Assigning source |
Provided by publisher. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
'Preface According to the World Health Organization's International Agency for Research on Cancer (IARC) (Technical Publication No. 24, 1994), genotoxicity is defined as structural changes at the level of a gene. It is also defined as a broad term that refers to any deleterious change in the genetic material regardless of the mechanism by which the change is induced, as stated by ICH S2(R1),'Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.' Genotoxic compounds have the theoretical potential to damage DNA at any level of exposure, leading to tumor development. This makes the toxicological assessment and determination of acceptable limits of genotoxic impurities (GTIs) difficult. GTIs have become an intensely debated topic in the pharmaceutical industry in recent years. My experiences in the internal and external discussions in meetings and conferences indicate that there is a great deal of confusion and uncertainty over identification, assessment, and control of GTIs. GTIs require different rationale and strategies from'regular' or'ordinary' impurities. Proper management of GTIs entails appropriate guidance and strategies, effective communication between various disciplines, sharing information and results, and understanding of the overall implications. The goal of this book is to present the rationale, strategies, methods, interpretation, practices, and case studies in the pharmaceutical industry in order to facilitate scientific and systematic consensus establishment on GTIs'-- |
| Assigning source |
Provided by publisher. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
MEDICAL / Pharmacology. |
| Source of heading or term |
bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
SCIENCE / Chemistry / Analytic. |
| Source of heading or term |
bisacsh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
SCIENCE / Research & Methodology. |
| Source of heading or term |
bisacsh |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Mutagenicity Tests |
| General subdivision |
methods. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Mutagens |
| General subdivision |
adverse effects. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Mutagens |
| General subdivision |
toxicity. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Toxicologie g{u296E}ique. |
| Source of heading or term |
ram |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Micaments |
| General subdivision |
Toxicologie. |
| Source of heading or term |
ram |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Mutag{u196E}es. |
| Source of heading or term |
ram |
| 650 17 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Mutagenicity Tests |
| General subdivision |
methods. |
| Source of heading or term |
mesh |
| 650 27 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Mutagens |
| General subdivision |
adverse effects. |
| Source of heading or term |
mesh |
| 650 27 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Mutagens |
| General subdivision |
toxicity. |
| Source of heading or term |
mesh |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Drugs |
| General subdivision |
Toxicology. |
| Source of heading or term |
fast |
| Authority record control number or standard number |
(OCoLC)fst00898958 |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Genetic toxicology. |
| Source of heading or term |
fast |
| Authority record control number or standard number |
(OCoLC)fst00940097 |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Lee, Heewon, |
| Relator term |
editor. |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Chromatographic science ; |
| Volume/sequential designation |
v. 107. |
| 856 42 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
Cover image |
| Uniform Resource Identifier |
<a href="http://images.tandf.co.uk/common/jackets/websmall/978143987/9781439874202.jpg">http://images.tandf.co.uk/common/jackets/websmall/978143987/9781439874202.jpg</a> |
| 907 ## - LOCAL DATA ELEMENT G, LDG (RLIN) |
|---|
| a |
.b16215011 |
| b |
2019-11-12 |
| c |
2019-11-12 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
AM |
| Suppress in OPAC |
No |
| Call number prefix |
QU550.5.M8P536 2015 9 |
| 914 ## - VTLS Number |
|---|
| VTLS Number |
vtls003594122 |
| 990 ## - EQUIVALENCES OR CROSS-REFERENCES [LOCAL, CANADA] |
|---|
| Link information for 9XX fields |
zr |
| 991 ## - LOCAL NOTE (NAMA FAKULTI/INSTITUT/PUSAT) |
|---|
| a |
Fakulti Farmasi, KKL |
| 998 ## - LOCAL CONTROL INFORMATION (RLIN) |
|---|
| Library |
PERPUSTAKAAN DR ABDUL LATIFF |
| Operator's initials, OID (RLIN) |
2015-07-10 |
| Cataloger's initials, CIN (RLIN) |
m |
| Material Type (Sierra) |
Printed Books |
| Language |
English |
| Country |
|
| -- |
0 |
| -- |
.b16215011 |
