Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines / (Record no. 247305)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04155cam a2200493Ki 4500 |
| 001 - CONTROL NUMBER | |
| control field | ocn945375877 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OCoLC |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20190328114814.0 |
| 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 cnu---unuuu |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 160322s2016 enk ob 001 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | OPELS |
| Language of cataloging | eng |
| Description conventions | rda |
| -- | pn |
| Transcribing agency | OPELS |
| Modifying agency | UIU |
| -- | OCLCF |
| -- | GGVRL |
| -- | TMC |
| -- | OCLCO |
| -- | UIU |
| -- | MERER |
| -- | OCLCO |
| -- | OCLCQ |
| -- | LEATE |
| -- | U3W |
| -- | OCLCA |
| -- | BUF |
| -- | OCLCO |
| -- | D6H |
| -- | UUM |
| -- | AU@ |
| -- | OCLCQ |
| 019 ## - | |
| -- | 951033138 |
| -- | 956735896 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780128042588 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 0128042583 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9780128042175 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 0128042176 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)945375877 |
| Canceled/invalid control number | (OCoLC)951033138 |
| -- | (OCoLC)956735896 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | R853.C55 |
| 060 #4 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
| Classification number | QV 771.4 |
| Item number | B864c |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.50724 |
| Edition number | 23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Brody, Tom, |
| Relator term | author. |
| 245 10 - TITLE STATEMENT | |
| Title | Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines / |
| Medium | [electronic resource] |
| Statement of responsibility, etc. | Tom Brody, Ph. D. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 2nd ed. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | London : |
| Name of producer, publisher, distributor, manufacturer | Academic Press is an imprint of Elsevier, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2016. |
| 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 |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Clinical Trials, Second Edition, 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. |
| 500 ## - GENERAL NOTE | |
| General note | Includes index. |
| 588 0# - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | Online resource; title from PDF title page (ScienceDirect, viewed March 22, 2016). |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 1. Origins of drugs -- 2. Clinical trial design -- 3. Run-in period -- 4. Inclusion/exclusion criteria, stratification, and subgroups -- part I -- 5. Inclusion/exclusion criteria, stratification, and subgroups -- part II -- 6. Blinding, randomization, and allocation -- 7. Placebo arm as part of clinical trial design -- 8. Intent-to-treat analysis versus per protocol analysis -- 9. Biostatistics -- part I -- 10. Biostatistics -- part II -- 11. Introduction to endpoints -- 12. Oncology endpoint -- objective response -- 13. Oncology endpoints : overall survival and progression-free survival -- 14. Oncology endpoints : time to progression -- 15. Oncology endpoint : disease-free survival -- 16. Oncology endpoint : time to distant metastasis -- 17. Neoadjuvant therapy versus adjuvant therapy -- 18. Hematological cancers -- 19. Biomarkers -- 20. Endpoints for immune diseases -- 21. Endpoints for infections -- 22. Health-related quality of life tools -- oncology -- 23. Health-related quality-of-life tools -- immune disorders -- 24. Health-related quality-of-life tools -- infections -- 25. Drug safety -- 26. Mechanism of action of diseases and drugs -- part I -- 27. Mechanism of action -- part II (cancer) -- 28. Mechanism of action -- part III (immune disorders) -- 29. Mechanisms of action -- part IV (infections) -- 30. Consent forms -- 31. Package inserts -- 32. Warning letters -- 33. Regulatory approval -- 34. Patents. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Clinical trials |
| General subdivision | Design. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Clinical trials |
| General subdivision | Design. |
| Source of heading or term | fast |
| Authority record control number | (OCoLC)fst00864431 |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Clinical Trials as Topic. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drug Approval. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Research Design. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Clinical Trials Data Monitoring Committees. |
| 655 #4 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| Main entry heading | Brody, Tom. |
| Title | Clinical Trials : Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. |
| Place, publisher, and date of publication | Saint Louis : Elsevier Science, �2016 |
| International Standard Book Number | 9780128042175 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Materials specified | ScienceDirect |
| Uniform Resource Identifier | http://www.sciencedirect.com/science/book/9780128042175 |
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