عنوان

Handbook of adaptive designs in pharmaceutical and clinical development

شابک

1439810168

شابک

9781439810163

شماره

dltt

عنوان اصلي

Handbook of adaptive designs in pharmaceutical and clinical development

نام عام مواد

[Book]

نام نخستين پديدآور

edited by Annpey Pong, Shein-Chung Chow.

محل نشرو پخش و غیره

Boca Raton, FL :

نام ناشر، پخش کننده و غيره

CRC Press,

تاریخ نشرو بخش و غیره

c2011.

متن يادداشت

Includes bibliographical references and index.

متن يادداشت

Overview of adaptive design methods in clinical trials / Annpey Pong and Shein-Chung Chow -- Fundamental theory of adaptive designs with unplanned design change in clinical trials with blinded data / Qing Liu and George Y. H. Chi -- Bayesian approach for adaptive design / Guosheng Yin and Ying Yuan -- The impact of protocol amendments in adaptive trial designs / Shein-Chung Chow and Annpey Pong -- From group sequential to adaptive designs / Christopher Jennison and Bruce W. Turnbull -- Determining sample size for classical designs / Simon Kirby and Christy Chuang-Stein -- Sample size reestimation design with applications in clinical trials / Lu Cui and Xiaoru Wu -- Adaptive interim analyses in clinical trials / Gernot Wassmer -- Classical dose-finding trial / Naitee Ting -- Improving dose-finding: a philosophic view / Carl-Fredrik Burman, Frank Miller, and Kiat Wee Wong -- Adaptive dose-ranging studies / Marc Vandemeulebroecke ... [et al.] -- Seamless phase I/II designs / Vladimir Dragalin -- Phase II/III seamless designs / Jeff Maca -- Sample size estimation/allocation for two-stage seamless adaptive trial designs / Shein-Chung Chow and Annpey Pong -- Optimal response-adaptive randomization for clinical trials / Lanju Zhang and William Rosenberger -- Hypothesis-adaptive design / Gerhard Hommel -- Treatment adaptive allocations in randomized clinical trials: an overview / Atanu Biswas and Rahul Bhattacharya -- Integration of predictive biomarker diagnostics into clinical trials for new drug development / Richard Simon -- Clinical strategy for study endpoint selection / Siu Keung Tse, Shein-Chung Chow, and Qingshu Lu -- Adaptive infrastructure / Bill Byrom, Damian McEntegart, and Graham Nicholls / Independent data monitoring committees / Steven Snapinn and Qi Jiang -- Targeted clinical trials / Jen-Pei Liu -- Functional genome-wide association studies of longitudinal traits / Jiangtao Luo ... [et al.] -- Adaptive trial simulation / Mark Chang -- Efficiency of adaptive designs / Nigel Stallard and Tim Friede -- Case studies in adaptive design / Ning Li, Yonghong Gao, and Shiowjen Lee -- Good practices for adaptive clinical trials / Paul Gallo.

بدون عنوان

0

متن يادداشت

"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.

موضوع مستند نشده

Clinical trials, Handbooks, manuals, etc.

موضوع مستند نشده

Drugs-- Research-- Methodology, Handbooks, manuals, etc.

موضوع مستند نشده

Clinical Trials as Topic-- methods.

موضوع مستند نشده

Research Design.

موضوع مستند نشده

Statistics as Topic-- methods.

مستند نام اشخاص تاييد نشده

Chow, Shein-Chung,1955-

مستند نام اشخاص تاييد نشده

Pong, Annpey.

تاريخ عمليات

20190629164956.0

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y