MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02622nam a22003257i 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
4492 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
PILC |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20240831135156.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
160505b2012 xxu||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9780123919113 |
| 040 ## - CATALOGING SOURCE |
|---|
| Description conventions |
rda |
| Transcribing agency |
FEU-NRMF MEDICAL LIBRARY |
| Language of cataloging |
eng |
| 050 ## - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
R 853 .C55 .B763 2012 |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Brody, Tom |
| 245 ## - TITLE STATEMENT |
|---|
| Title |
Clinical trials : |
| Remainder of title |
study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines / |
| Statement of responsibility, etc. |
Tom. Brody. |
| 264 ## - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE |
|---|
| Place of production, publication, distribution, manufacture |
Amsterdam : |
| Name of producer, publisher, distributor, manufacturer |
Academic Press / Elsevier, |
| Date of production, publication, distribution, manufacture, or copyright notice |
2012. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
638 pages |
| 336 ## - CONTENT TYPE |
|---|
| Content type term |
Text |
| 337 ## - MEDIA TYPE |
|---|
| Media type term |
Unmediated |
| 338 ## - CARRIER TYPE |
|---|
| Carrier type term |
Volume |
| 500 ## - GENERAL NOTE |
|---|
| General note |
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design. Provides extensive coverage of the "study schema" and related features of study design Offers a "hands-on" reference that contains an overview of the process, but more importantly details a step-by-step account of clinical trial design Features examples from the medical literature to highlight how investigators choose the most suitable endpoint(s) for clinical trial and includes graphs from real clinical trials to help explain each concept in study design Integrates clinical trial design, pharmacology, biochemistry, cell biology and legal aspects to provide readers with a comprehensive look at all aspects of clinical trials. |
| 500 ## - GENERAL NOTE |
|---|
| General note |
Includes bibliographical references and index. |
| 521 ## - TARGET AUDIENCE NOTE |
|---|
| Target audience note |
Ethics |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Clinical Trials as Topic. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Clinical Trials Data Monitoring Committees. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Clinical trials |
| General subdivision |
Design. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Approval. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Research Design. |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
|---|
| Enable Ebook |
Yes |
| Link text |
Click here to view TABLE OF CONTENTS and INDEX. |
| Uniform Resource Identifier |
<a href="https://library.feu-nrmf.ph/cgi-bin/koha/opac-retrieve-file.pl?id=034d1d90bd1e4aaad711b3eb61d72dcc">https://library.feu-nrmf.ph/cgi-bin/koha/opac-retrieve-file.pl?id=034d1d90bd1e4aaad711b3eb61d72dcc</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
Library of Congress Classification |
| Koha item type |
Books Overnight |
