MARC details
| 000 -LEADER |
|---|
| fixed length control field |
04124cam a2200517 i 4500 |
| 041 ## - LANGUAGE CODE |
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| Language code of text/sound track or separate title |
İngilizce |
| 001 - CONTROL NUMBER |
|---|
| control field |
1345279246 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20241121093255.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS |
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| fixed length control field |
m o d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
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| fixed length control field |
cr ||||||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
220707s2023 nju ob 001 0 eng |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9781119867401 |
| Qualifying information |
(epub) |
|
|---|
| International Standard Book Number |
1119867401 |
|
|---|
| International Standard Book Number |
9781119867395 |
| Qualifying information |
(adobe pdf) |
|
|---|
| International Standard Book Number |
1119867398 |
|
|---|
| Canceled/invalid ISBN |
9781119867388 |
| Qualifying information |
(hardback) |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(OCoLC)1345279246 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DLC |
| Language of cataloging |
eng |
| Description conventions |
rda |
| Transcribing agency |
DLC |
| Modifying agency |
UKAHL |
| 060 00 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
|---|
| Classification number |
QV 771.4 |
| 096 ## - LOCALLY ASSIGNED NLM-TYPE CALL NUMBER (OCLC) |
|---|
| Classification number |
QV771.4 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Kay, R. |
| Fuller form of name |
(Richard), |
| Dates associated with a name |
1949- |
| Authority record control number or standard number |
https://id.loc.gov/authorities/names/n82119999 |
| Relator term |
author |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Statistical thinking for non-statisticians in drug regulation / |
| Statement of responsibility, etc. |
Richard Kay |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
Third edition |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
Hoboken, NJ : |
| Name of producer, publisher, distributor, manufacturer |
Wiley-Blackwell, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2023 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
1 online resource |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
text |
| Content type code |
txt |
| Source |
rdacontent |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
computer |
| Media type code |
c |
| Source |
rdamedia |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
online resource |
| Carrier type code |
cr |
| Source |
rdacarrier |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Basic ideas in clinical trial design -- Sampling and inferential statistics -- Confidence intervals and p-values -- Tests for simple treatment comparisons -- Adjusting the analysis -- Regression and analysis of covariance -- Intention-to-treat and analysis sets -- Power and sample size -- Statistical significance and clinical importance -- Multiple testing -- Non-parametric and related methods -- Equivalence and non-inferiority -- The analysis of survival data -- Interim analysis and data monitoring committees -- Bayesian statistics -- Adaptive designs -- Observational studies -- Meta-analysis -- Methods for the safety analysis and safety monitoring -- Diagnosis -- The role of statistics and statisticians |
| 506 ## - RESTRICTIONS ON ACCESS NOTE |
|---|
| Terms governing access |
Available to OhioLINK libraries |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc. |
Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name entry element |
Clinical trials |
| General subdivision |
Statistical methods. |
| Authority record control number or standard number |
https://id.loc.gov/authorities/subjects/sh2009120433 |
|
|---|
| Topical term or geographic name entry element |
Drugs |
| General subdivision |
Testing |
| Authority record control number or standard number |
https://id.loc.gov/authorities/subjects/sh85039755 |
| General subdivision |
Statistical methods. |
| Authority record control number or standard number |
https://id.loc.gov/authorities/subjects/sh2001008679 |
|
|---|
| Topical term or geographic name entry element |
Drug approval |
| Authority record control number or standard number |
https://id.loc.gov/authorities/subjects/sh2002008777 |
| General subdivision |
Statistical methods. |
| Authority record control number or standard number |
https://id.loc.gov/authorities/subjects/sh2001008679 |
|
|---|
| Topical term or geographic name entry element |
Pharmaceutical industry |
| Authority record control number or standard number |
https://id.loc.gov/authorities/subjects/sh85039713 |
| General subdivision |
Statistical methods. |
| Authority record control number or standard number |
https://id.loc.gov/authorities/subjects/sh2001008679 |
|
|---|
| Topical term or geographic name entry element |
Clinical Trials as Topic |
| General subdivision |
methods. |
| Authority record control number or standard number |
https://id.nlm.nih.gov/mesh/D002986Q000379 |
|
|---|
| Topical term or geographic name entry element |
Drug Approval. |
| Authority record control number or standard number |
https://id.nlm.nih.gov/mesh/D017277 |
|
|---|
| Topical term or geographic name entry element |
Statistics as Topic. |
| Authority record control number or standard number |
https://id.nlm.nih.gov/mesh/D013223 |
| 9 (RLIN) |
117232 |
|
|---|
| Topical term or geographic name entry element |
Drug Industry. |
| Authority record control number or standard number |
https://id.nlm.nih.gov/mesh/D004345 |
| 9 (RLIN) |
23084 |
| 655 #0 - INDEX TERM--GENRE/FORM |
|---|
| Genre/form data or focus term |
Electronic books |
| 9 (RLIN) |
2032 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Relationship information |
Print version: |
| Main entry heading |
Kay, Richard, 1949- |
| Title |
Statistical thinking for non-statisticians in drug regulation |
| Edition |
Third edition. |
| Place, publisher, and date of publication |
Hoboken, NJ : Wiley-Blackwell, 2023 |
| International Standard Book Number |
9781119867388 |
| Record control number |
(DLC) 2022032464 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
Wiley Online Library |
| Public note |
Connect to resource |
| Uniform Resource Identifier |
<a href="https://onlinelibrary.wiley.com/doi/book/10.1002/9781119867418">https://onlinelibrary.wiley.com/doi/book/10.1002/9781119867418</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
National Library of Medicine |
| Koha item type |
E-Book |
