Handbook of adaptive designs in pharmaceutical and clinical development (Record no. 11143)
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| 000 -LEADER | |
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| fixed length control field | 04276nam a2200349Ia 4500 |
| 001 - CONTROL NUMBER | |
| control field | CRC0KE10476PDF |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | BD-DhSAU |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20151012144300.0 |
| 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|||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 110310s2011 fluad sbf 001 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781439810170 (ebook : PDF) |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | BD-DhSAU |
| Transcribing agency | BD-DhSAU |
| 090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (OCLC) | |
| Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) | R853.C55 |
| Local cutter number (OCLC) ; Book number/undivided call number, CALL (RLIN) | H355 2011 |
| 092 ## - LOCALLY ASSIGNED DEWEY CALL NUMBER (OCLC) | |
| Classification number | 615.50724 |
| Item number | H236 |
| 245 00 - TITLE STATEMENT | |
| Title | Handbook of adaptive designs in pharmaceutical and clinical development |
| Medium | [electronic resource] / |
| Statement of responsibility, etc. | edited by Annpey Pong, Shein-Chung Chow. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc. | Boca Raton : |
| Name of publisher, distributor, etc. | CRC Press, |
| Date of publication, distribution, etc. | 2011. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 v. (various pagings) : |
| Other physical details | ill. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc | Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 1. Overview of adaptive design methods in clinical trials / Annpey Pong and Shein-Chung Chow -- 2. Fundamental theory of adaptive designs with unplanned design change in clinical trials with blinded data / Qing Liu and George Y.H. Chi -- 3. Bayesian approach for adaptive design / Guosheng Yin and Ying Yuan -- 4. The impact of protocol amendments in adaptive trial designs / Shein-Chung Chow and Annpey Pong -- 5. From group sequential to adaptive designs / Christopher Jennison and Bruce W. Turnbull -- 6. Determining sample size for classical designs / Simon Kirby and Christy Chuang-Stein -- 7. Sample size reestimation design with applications in clinical trials / Lu Cui and Xiaoru Wu -- 8. Adaptive interim analyses in clinical trials / Gernot Wassmer -- 9. Classical dose-finding trial / Naitee Ting -- 10. Improving dose-finding : a philosophic view / Carl-Fredrik Burman, Frank Miller, and Kiat Wee Wong -- 11. Adaptive dose-ranging studies / Marc Vandemeulebroecke ... [et al.] -- 12. Seamless phase I/II designs / Vladimir Dragalin -- 13. Phase II/III seamless designs / Jeff Maca -- 14. Sample size estimation/allocation for two-stage seamless adaptive trial designs / Shein-Chung Chow and Annpey Pong -- 15. Optimal response-adaptive randomization for clinical trials / Lanju Zhang and William Rosenberger -- 16. Hypothesis-adaptive design / Gerhard Hommel -- 17. Treatment adaptive allocations in randomized clinical trials : an overview / Atanu Biswas and Rahul Bhattacharya -- 18. Integration of predictive biomarker diagnostics into clinical trials for new drug development / Richard Simon -- 19. Clinical strategy for study endpoint selection / Siu Keung Tse, Shein-Chung Chow, and Qingshu Lu -- 20. Adaptive infrastructure / Bill Byrom, Damian McEntegart, and Graham Nicholls -- |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | 21. Independent data monitoring committees / Steven Snapinn and Qi Jiang -- 22. Targeted clinical trials / Jen-Pei Liu -- 23. Functional genome-wide association studies of longitudinal traits / Jiangtao Luo ... [et al.] -- 24. Adaptive trial simulation / Mark Chang -- 25. Efficiency of adaptive designs / Nigel Stallard and Tim Friede -- 26. Case studies in adaptive design / Ning Li, Yonghong Gao, and Shiowjen Lee -- 27. Good practices for adaptive clinical trials / Paul Gallo. |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | "This comprehensive guide offers a unified presentation of the principles and methodologies in adaptive design and analysis. It gives a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. The handbook provides some insight regarding early phase and later phase adaptive designs. With a focus on the implementation of adaptive methods in clinical trials, it introduces the concepts of role, responsibility, function, and activity of a data safety monitoring board (DSMB) when applying these methods. Other important topics covered in detail include regulatory perspectives and logistics issues in applying adaptive design methods"--Provided by publisher. |
| 530 ## - ADDITIONAL PHYSICAL FORM AVAILABLE NOTE | |
| Additional physical form available note | Also available in print edition. |
| 538 ## - SYSTEM DETAILS NOTE | |
| System details note | Mode of access: World Wide Web. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Clinical trials |
| Form subdivision | Handbooks, manuals, etc. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | Drugs |
| General subdivision | Research |
| -- | Methodology |
| Form subdivision | Handbooks, manuals, etc. |
| 655 #7 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| Source of term | lcsh |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Pong, Annpey. |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Chow, Shein-Chung, |
| Dates associated with a name | 1955- |
| 776 1# - ADDITIONAL PHYSICAL FORM ENTRY | |
| International Standard Book Number | 9781439810163 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://marc.crcnetbase.com/isbn/9781439810170">http://marc.crcnetbase.com/isbn/9781439810170</a> |
| Electronic format type | application/PDF |
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