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20250320173145.0 |
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220906s2023 nju ob 001 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
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| LC control number |
2022042521 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9781119755852 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9781119755876 |
| Qualifying information |
(epub) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9781119755869 |
| Qualifying information |
(adobe pdf) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| Cancelled/invalid ISBN |
9781119755852 |
| Qualifying information |
(cloth) |
| 041 ## - LANGUAGE CODE |
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| Language code of text/sound track or separate title |
eng. |
| 042 ## - AUTHENTICATION CODE |
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| Authentication code |
pcc |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
RA1238 |
| 060 10 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
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| Classification number |
QV 771 |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Classification number |
615/.19 |
| Edition number |
23/eng/20221110 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
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| Preferred name for the person |
Gad, Shayne C., |
| Dates associated with a name |
1948- |
| Relator term |
author. |
| 245 10 - TITLE STATEMENT |
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| Title |
Drug safety evaluation / |
| Statement of responsibility, etc |
Shayne Cox Gad, Dexter W. Sullivan Jr. |
| 250 ## - EDITION STATEMENT |
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| Edition statement |
4th edition. |
| 263 ## - PROJECTED PUBLICATION DATE |
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| Projected publication date |
2212 |
| 264 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
Hoboken, NJ : |
| Name of publisher, distributor, etc |
Wiley, |
| Date of publication, distribution, etc |
2023. |
| 300 ## - PHYSICAL DESCRIPTION |
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| Extent |
1 online resource |
| 336 ## - CONTENT TYPE |
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| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
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| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
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| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 0# - CONTENTS |
|---|
| Formatted contents note |
Table of Contents<br/>PREFACE xxix<br/><br/>ABOUT THE AUTHORS xxxi<br/><br/>1 The Drug Development Process and The Global Pharmaceutical Marketplace 1<br/><br/>2 Regulation of Human Pharmaceutical Safety: Routes To Human Use and Market 19<br/><br/>3 Data Mining: Sources of Information For Consideration In Study And Program Design and In Safety Evaluation 67<br/><br/>4 Electronic Records, Reporting, and Submission: eCTD and Send 75<br/><br/>5 Screens in Safety and Hazard Assessment 83<br/><br/>6 Formulations, Routes, and Dosage Regimens 95<br/><br/>7 Mechanisms And End Points Of Drug Toxicity 131<br/><br/>8 Pilot Toxicity Testing In Drug Safety Evaluation: MTD and DRF 143<br/><br/>9 Repeat-Dose Toxicity Studies 173<br/><br/>10 Genotoxicity 183<br/><br/>11 QSAR Tools For Drug Safety 223<br/><br/>12 Toxicogenomics 241<br/><br/>13 Immunotoxicology In Drug Development 247<br/><br/>14 Nonrodent Animal Studies 293<br/><br/>15 Developmental And Reproductive Toxicity Testing 331<br/><br/>16 Carcinogenicity Studies 363<br/><br/>17 Histopathology and Clinical Pathology In Nonclinical Pharmaceutical Safety Assessment 395<br/><br/>18 Irritation And Local Tissue Tolerance In Pharmaceutical Safety Assessment 403<br/><br/>19 Pharmacokinetics And Toxicokinetics In Drug Safety Evaluation 425<br/><br/>20 Safety Pharmacology 457<br/><br/>21 Special Concerns For The Preclinical Evaluation Of Biotechnology Products 477<br/><br/>22 Safety Assessment of Inhalant Drugs And Dermal Route Drugs 507<br/><br/>23 Special Case Products: Imaging Agents 529<br/><br/>24 Special Case Products: Drugs For Treatment Of Cancer 535<br/><br/>25 Pediatric Product Safety Assessment (2006 Guidance, Including Juvenile And Pediatric Toxicology) 543<br/><br/>26 Use Of Imaging, Imaging Agents, And Radiopharmaceuticals In Nonclinical Toxicology 551<br/><br/>27 Occupational Toxicology In The Pharmaceutical Industry 571<br/><br/>28 Strategy and Phasing For Nonclinical Drug Safety EvaluationIn The Discovery and Development of Pharmaceuticals 585<br/><br/>29 The Application of In Vitro Techniques In Drug Safety Assessment 603<br/><br/>30 Evaluation Of Human Tolerance And Safety In Clinical Trials: Phase I And Beyond 635<br/><br/>31 Postmarketing Safety Evaluation: Monitoring, Assessing, And Reporting of Adverse Drug Responses (ADRs) 683<br/><br/>32 Statistics In Pharmaceutical Safety Assessment 707<br/><br/>33 Combination Products: Drugs and Devices 767<br/><br/>34 Qualification Of Impurities, Degradants, Residual Solvents, Metals, and Leachables in Pharmaceuticals 777<br/><br/>35 Tissue, Cell, and Gene Therapy 789<br/><br/>36 Adverse Outcome Pathways in Drug Safety Assessment 801<br/><br/>Appendix A: Selected Regulatory and Toxicological Acronyms 805<br/><br/>Appendix B: Definition Of Terms And Lexicon of "Clinical" Observations in Nonclinical (Animal) Studies 807<br/><br/>Appendix C: Notable Regulatory Internet Addresses 811<br/><br/>Appendix D: Glossary Of Terms Used in The Clinical Evaluation of Therapeutic Agents 817<br/><br/>Appendix E: Common Vehicles For The Nonclinical Evaluation of Therapeutic Agents 821<br/><br/>Appendix F: Global Directory of Contract Toxicology Labs 919<br/><br/>INDEX 945 |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
"This new edition of Drug Safety Evaluation presents an all-inclusive practical guide for those who are responsible for developing new drugs and ensuring the safety of an ever-expanding spectrum of therapeutics. This book helps readers understand how the safety of these products are evaluated for use. Extensively revised to reflect up-to-date information, this edition includes changes to the scope of products (vaccines, small synthetic, large protein moieties, cells and tissues), harmonized global and national regulatory requirements, the therapeutic development process, and available technologies to identify and evaluate the relevance of potential patient risks. The revised chapter, and inclusion of brand-new chapters, address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Also covered are the scientific and philosophical bases for evaluation of specific concerns (including carcinogenicity, developmental toxicity, immunogenicity and immunotoxicity) to provide both understanding and guidance for approaching new problems"-- |
| Assigning source |
Provided by publisher. |
| 545 0# - BIOGRAPHICAL OR HISTORICAL DATA |
|---|
| Biographical or historical note |
About the Author<br/>Shayne Cox Gad, PhD, DABT is the Principal of Gad Consulting Services. He has more than 47 years of experience as a toxicologist, statistical consultant, manager, and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He has successfully file 138 INDs and authored and edited 52 books, as well as numerous papers, presentations, and other publications.<br/><br/>Dexter W. Sullivan, Jr., MS, DABT is Senior Toxicologist at Gad Consulting Services. |
| 588 ## - SOURCE OF DESCRIPTION NOTE |
|---|
| Source of description note |
Description based on print version record and CIP data provided by publisher; resource not viewed. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Evaluation, Preclinical |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Evaluation |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Product Surveillance, Postmarketing |
| 655 #4 - INDEX TERM--GENRE/FORM |
|---|
| Source of term |
Electronic books. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Sullivan, Dexter W., |
| Titles and other words associated with a name |
Jr. |
| Relator term |
author. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Link text |
Full text available at Wiley Online Library Click here to view. |
| Uniform Resource Identifier |
https://onlinelibrary.wiley.com/doi/book/10.1002/9781119755883 |
| 942 ## - ADDED ENTRY ELEMENTS |
|---|
| Source of classification or shelving scheme |
|
| Item type |
EBOOK |