Clinical Trials (notice n° 14625)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 02100cam a2200277zu 4500 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | FRCYB88832132 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20250107103925.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 250107s2016 fr | o|||||0|0|||eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780128042175 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | FRCYB88832132 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | FR-PaCSA |
| Language of cataloging | en |
| Transcribing agency | |
| Description conventions | rda |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Brody, Tom |
| 245 01 - 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'] |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Name of producer, publisher, distributor, manufacturer | Elsevier Science |
| Date of production, publication, distribution, manufacture, or copyright notice | 2016 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | p. |
| 336 ## - CONTENT TYPE | |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type code | c |
| Source | rdamdedia |
| 338 ## - CARRIER TYPE | |
| Carrier type code | c |
| 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.Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and moreExtensively covers the "study schema" and related features of study designIncorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trialsIncludes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | |
| 700 0# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Brody, Tom |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Access method | Cyberlibris |
| Uniform Resource Identifier | <a href="https://international.scholarvox.com/netsen/book/88832132">https://international.scholarvox.com/netsen/book/88832132</a> |
| Electronic format type | text/html |
| Host name | |
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