Clinical trials : (Record no. 87258)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02876nam a2200289Ia 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 230719s2016 xx 000 0 und d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780128042175 |
| 050 ## - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | R 853.C55 B76 2016 |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) | |
| Classification number | 15835 |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Brody, Tom |
| 245 10 - TITLE STATEMENT | |
| Title | Clinical trials : |
| Remainder of title | study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines/ |
| Statement of responsibility, etc. | Brody, Tom. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | Second edition. |
| 264 ## - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Amsterdam, Netherlands : |
| Name of producer, publisher, distributor, manufacturer | |
| -- | Elsevier/Academic Press, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2016. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | xxxii, 863 pages : |
| Other physical details | some illustrations ; |
| Dimensions | 24 cm. |
| 500 ## - GENERAL NOTE | |
| General note | Includes bibliographical references and index. |
| 505 ## - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Origins of drugs -- Clinical trial design -- Run-in period -- Inclusion/exclusion criteria, stratification, and subgroups, part I -- Inclusion/exclusion criteria, stratification, and subgroups, part II -- Blinding, randomization, and allocation -- Placebo arm as part of clinical trial design -- Intent-to-treat analysis versus per protocol analysis -- Biostatistics, part I -- Biostatistics, part II -- Introduction to endpoints -- Oncology endpoints : overall survival and progression-free survival -- Oncology endpoints : time to progression -- Oncology endpoint : disease-free survival -- Oncology endpoint : time to distant metastasis -- Neoadjuvant therapy versus adjuvant therapy -- Hematological cancers -- Biomarkers -- Endpoints for immune diseases -- Endpoints for infections -- Health-related quality of life tools --oncology -- Health-related quality-of-life tools --immune disorders -- Health-related quality-of-life tools --infections -- Drug safety -- Mechanism of action of diseases and drugs, part I -- Mechanism of action, part II (cancer) -- Mechanism of action, part III (immune disorders) -- Mechanisms of action, part IV (infections) -- Consent forms -- Package inserts -- Warning letters -- Regulatory approval -- Patents. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | This text offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. |
| 521 ## - TARGET AUDIENCE NOTE | |
| Target audience note | |
| 590 ## - LOCAL NOTE (RLIN) | |
| Local note | MEDICINE |
| 591 ## - | |
| -- | /Brody, Tom. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Clinical trials |
| General subdivision | Design. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Clinical trials as topic. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Drug approval. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Drugs |
| General subdivision | Testing. |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Research design. |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Library of Congress Classification |
| Classification part | R |
| Koha item type | MEDICINE BOOKS |
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