1.

Record Nr.

UNINA9910459136803321

Titolo

Handbook of adaptive designs in pharmaceutical and clinical development / / edited by Annpey Pong, Shein-Chung Chow

Pubbl/distr/stampa

Boca Raton : , : CRC Press, , 2011

ISBN

0-429-13066-X

1-283-00453-4

9786613004536

1-4398-1017-6

Descrizione fisica

1 online resource (475 p.)

Altri autori (Persone)

PongAnnpey

ChowShein-Chung <1955->

Disciplina

615.5072/4

Soggetti

Clinical trials

Drugs - Research - Methodology

Electronic books.

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references and index.

Nota di contenuto

Front cover; Contents; Preface; Editors; Contributors; Chapter 1. Overview of Adaptive Design Methods in Clinical Trials; Chapter 2. Fundamental Theory of Adaptive Designs with Unplanned Design Change in Clinical Trials with Blinded Data; Chapter 3. Bayesian Approach for Adaptive Design; Chapter 4. The Impact of Protocol Amendments in Adaptive Trial Designs; Chapter 5. From Group Sequential to Adaptive Designs; Chapter 6. Determining Sample Size for Classical Designs; Chapter 7. Sample Size Reestimation Design with Applications in Clinical Trials

Chapter 8. Adaptive Interim Analyses in Clinical TrialsChapter 9. Classical Dose-Finding Trial; Chapter 10. Improving Dose-Finding: A Philosophic View; Chapter 11. Adaptive Dose-Ranging Studies; Chapter 12. Seamless Phase I/II Designs; Chapter 13. Phase II/III Seamless Designs; Chapter 14. Sample Size Estimation/Allocation for Two-Stage Seamless Adaptive Trial Designs; Chapter 15. Optimal Response-Adaptive Randomization for Clinical Trials; Chapter 16. Hypothesis-Adaptive Design; Chapter 17. Treatment Adaptive Allocations in



Randomized Clinical Trials: An Overview

Chapter 18. Integration of Predictive Biomarker Diagnostics into Clinical Trials for New Drug DevelopmentChapter 19. Clinical Strategy for Study Endpoint Selection; Chapter 20. Adaptive Infrastructure; Chapter 21. Independent Data Monitoring Committees; Chapter 22. Targeted Clinical Trials; Chapter 23. Functional Genome-Wide Association Studies of Longitudinal Traits; Chapter 24. Adaptive Trial Simulation; Chapter 25. Efficiency of Adaptive Designs; Chapter 26. Case Studies in Adaptive Design; Chapter 27. Good Practices for Adaptive Clinical Trials; Back cover

Sommario/riassunto

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.



2.

Record Nr.

UNINA9910969402003321

Titolo

Karel ende Elegast / / bezorgd door Geert Claassens

Pubbl/distr/stampa

Amsterdam, : Amsterdam University Press, c2002

ISBN

1-282-45398-X

9786612453984

90-485-0841-X

Edizione

[1st ed.]

Descrizione fisica

1 online resource (65 p.)

Collana

Alfa

Altri autori (Persone)

ClaassensGeert H. M

Disciplina

370

839.31

Soggetti

Epic poetry, Dutch

Poetry, Medieval

Lingua di pubblicazione

Olandese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references.

Nota di contenuto

Inhoud; Inleiding; Verantwoording; Bibliografie; Die historie van coninck Karel ende van Elegast

Sommario/riassunto

Karel de Grote (742-814), de illustere Frankische vorst die in 1165, ruim driehonderd na zijn dood, heilig werd verklaard, is uit vele middeleeuwse verhalen bekend. Hoewel hij altijd de rol van monarch vervult, wordt zijn personage wisselend neergezet. Soms verschijnt Karel als een daadkrachtig strijder en aanvoerder, soms als een twijfelaar en een enkele keer zelfs als een despoot die zich door slechte raadgevers laat misleiden. In 'Karel ende Elegast' zien we hem in een opmerkelijke dubbelrol: de grote koning speelt - in opdracht van God - voor dief. Maar door aan het goddelijke gebod te geh