MARC details
| 000 -LEADER |
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| fixed length control field |
03039nam a22004575i 4500 |
| 001 - CONTROL NUMBER |
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| control field |
978-3-319-22084-0 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20160405112920.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
151102s2015 gw | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9783319220840 |
| -- |
978-3-319-22084-0 |
| 024 7# - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1007/978-3-319-22084-0 |
| Source of number or code |
doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
RC261-271 |
| 072 #7 - SUBJECT CATEGORY CODE |
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| Subject category code |
MJCL |
| Source |
bicssc |
| 072 #7 - SUBJECT CATEGORY CODE |
|---|
| Subject category code |
MED062000 |
| Source |
bisacsh |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Classification number |
614.5999 |
| Edition number |
23 |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Genotoxicity and Carcinogenicity Testing of Pharmaceuticals |
| Medium |
[electronic resource] / |
| Statement of responsibility, etc |
edited by Michael J. Graziano, David Jacobson-Kram. |
| 250 ## - EDITION STATEMENT |
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| Edition statement |
1st ed. 2015. |
| 264 #1 - |
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| -- |
Cham : |
| -- |
Springer International Publishing : |
| -- |
Imprint: Springer, |
| -- |
2015. |
| 300 ## - PHYSICAL DESCRIPTION |
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| Extent |
X, 206 p. 15 illus., 8 illus. in color. |
| Other physical details |
online resource. |
| 336 ## - |
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| -- |
text |
| -- |
txt |
| -- |
rdacontent |
| 337 ## - |
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| -- |
computer |
| -- |
c |
| -- |
rdamedia |
| 338 ## - |
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| -- |
online resource |
| -- |
cr |
| -- |
rdacarrier |
| 347 ## - |
|---|
| -- |
text file |
| -- |
PDF |
| -- |
rda |
| 505 0# - FORMATTED CONTENTS NOTE |
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| Formatted contents note |
Introduction -- History and Current Regulatory Requirements -- Genotoxicity Testing of API and Impurities -- New Emerging Genotoxicity Tests -- Carcinogenicity Testing of Small Molecules -- Alternatives to the 2-Year Rodent Studies -- Addressing Positive Findings in Carcinogenicity Studies -- Investigating Tumor Signals in Clinical Trials -- Tumor Promoters -- Carcinogenicity Testing of Biologics -- In Silico Predictive Tests. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Medicine. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Cancer research. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical technology. |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Biomedicine. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Cancer Research. |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical Sciences/Technology. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Graziano, Michael J. |
| Relator term |
editor. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Jacobson-Kram, David. |
| Relator term |
editor. |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Display text |
Printed edition: |
| International Standard Book Number |
9783319220833 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
<a href="http://dx.doi.org/10.1007/978-3-319-22084-0">http://dx.doi.org/10.1007/978-3-319-22084-0</a> |
| 912 ## - |
|---|
| -- |
ZDB-2-SBL |
