Statistical methods for evaluating safety in medical product development / (Record no. 65060)
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| 001 - CONTROL NUMBER | |
| control field | sulb-eb0033408 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | BD-SySUS |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20170713221405.0 |
| 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 ||||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 140702s2014 enk ob 001 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER | |
| LC control number | 2014026252 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | DLC |
| Language of cataloging | eng |
| Description conventions | rda |
| Transcribing agency | DLC |
| Modifying agency | DG1 |
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| -- | N$T |
| -- | IDEBK |
| -- | OCLCF |
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| 019 ## - | |
| -- | 904024916 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781118763100 |
| Qualifying information | electronic bk. |
| International Standard Book Number | 1118763106 |
| Qualifying information | electronic bk. |
| Canceled/invalid ISBN | 9781118763094 |
| Canceled/invalid ISBN | 1118763092 |
| Canceled/invalid ISBN | 9781119979661 (cloth) |
| Canceled/invalid ISBN | 9781118763070 |
| Canceled/invalid ISBN | 1118763076 |
| Canceled/invalid ISBN | 1119979668 |
| Canceled/invalid ISBN | 9781322776293 |
| Canceled/invalid ISBN | 1322776296 |
| 028 01 - PUBLISHER NUMBER | |
| Publisher number | EB00593999 |
| Source | Recorded Books |
| 029 1# - OTHER SYSTEM CONTROL NUMBER (OCLC) | |
| OCLC library identifier | CHBIS |
| System control number | 010442316 |
| OCLC library identifier | CHVBK |
| System control number | 334088925 |
| OCLC library identifier | NZ1 |
| System control number | 15913643 |
| OCLC library identifier | CHVBK |
| System control number | 338338918 |
| OCLC library identifier | CHDSB |
| System control number | 006423090 |
| OCLC library identifier | DEBBG |
| System control number | BV042792720 |
| OCLC library identifier | DEBBG |
| System control number | BV043396955 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)882620442 |
| Canceled/invalid control number | (OCoLC)904024916 |
| 037 ## - SOURCE OF ACQUISITION | |
| Stock number | A025133C-1E63-4589-BDA2-4D7FED6A46F7 |
| Source of stock number/acquisition | OverDrive, Inc. |
| Note | http://www.overdrive.com |
| 042 ## - AUTHENTICATION CODE | |
| Authentication code | pcc |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | R853.C55 |
| 060 10 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
| Classification number | QV 771 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED |
| Subject category code subdivision | 071000 |
| Source | bisacsh |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.5072/4 |
| Edition number | 23 |
| 049 ## - LOCAL HOLDINGS (OCLC) | |
| Holding library | MAIN |
| 245 00 - TITLE STATEMENT | |
| Title | Statistical methods for evaluating safety in medical product development / |
| Statement of responsibility, etc. | editor Lawrence Gould, Merck Research Laboratories, USA. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Chichester, West Sussex, UK : |
| Name of producer, publisher, distributor, manufacturer | Wiley, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2014. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource. |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Source | rdacarrier |
| 490 1# - SERIES STATEMENT | |
| Series statement | Statistics in practice |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Safety graphics / A. Lawrence Gould -- QSAR modeling : prediction of biological activity from chemical structure / Andy Liaw and Vladimir Svetnik -- Ethical and practical issues in phase I trials in healthy volunteers / Stephen Senn -- Phase I trials / A. Lawrence Gould -- Summarizing adverse event risk / A. Lawrence Gould -- Statistical analysis of recurrent adverse events / Liqun Diao, Richard J. Cook, and Ker-Ai Lee -- Cardiovascular toxicity, especially QT/QTc prolongation / Arne Ring and Robert Schall -- Hepatic toxicity / Donald C. Trost -- Neurotoxicity / A. Lawrence Gould -- Safety monitoring / Jay Herson -- Sequential testing for safety evaluation / Jie Chen -- Evaluation of post-marketing safety using spontaneous reporting databases / Ismail Ahmed, Bernard Begaud, and Pascale Tubert-Bitter / Pharmacovigilance using observational/longitudinal databases and web-based information / A. Lawrence Gould. |
| 588 ## - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | Description based on print version record and CIP data provided by publisher. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. -Provides a guide to statistical methods and application in medical product development -Assists readers in undertaking design and analysis of experiments at various stages of product development -Features case studies throughout the book, as well as, SAS and R code. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug Evaluation |
| General subdivision | methods. |
| Topical term or geographic name as entry element | Clinical Trials as Topic. |
| Topical term or geographic name as entry element | Models, Statistical. |
| Topical term or geographic name as entry element | Pharmacovigilance. |
| Topical term or geographic name as entry element | Safety Management |
| General subdivision | methods. |
| Topical term or geographic name as entry element | Technology, Pharmaceutical |
| General subdivision | standards. |
| Topical term or geographic name as entry element | Clinical trials |
| General subdivision | Statistical methods. |
| Topical term or geographic name as entry element | MEDICAL |
| General subdivision | Pharmacology. |
| Source of heading or term | bisacsh |
| Topical term or geographic name as entry element | Clinical trials |
| General subdivision | Statistical methods. |
| Source of heading or term | fast |
| Authority record control number | (OCoLC)fst00864440 |
| Topical term or geographic name as entry element | Medical. |
| 655 #4 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Gould, Lawrence |
| Fuller form of name | (A. Lawrence), |
| Relator term | editor. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| Title | Statistical methods for evaluating safety in medical product development |
| Place, publisher, and date of publication | Chichester, West Sussex, United Kingdom ; Hoboken : John Wiley & Sons Inc., 2014 |
| International Standard Book Number | 9781119979661 |
| Record control number | (DLC) 2014025599 |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE | |
| Uniform title | Statistics in practice. |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://onlinelibrary.wiley.com/book/10.1002/9781118763070">http://onlinelibrary.wiley.com/book/10.1002/9781118763070</a> |
| Public note | Wiley Online Library [Free Download only for SUST IP] |
| 938 ## - | |
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| -- | Ingram Digital eBook Collection |
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| -- | YBP Library Services |
| -- | YANK |
| -- | 10706429 |
| -- | YBP Library Services |
| -- | YANK |
| -- | 12261973 |
| -- | Recorded Books, LLC |
| -- | RECE |
| -- | rbeEB00593999 |
| -- | EBL - Ebook Library |
| -- | EBLB |
| -- | EBL4038476 |
| 994 ## - | |
| -- | 92 |
| -- | DG1 |
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