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Author:   Nusrat Rabbee
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Weight:   0.453kg
ISBN:  

9781138368835

ISBN 10:   1138368830
Pages:   204
Publication Date:   01 April 2020
Audience:   College/higher education ,  General/trade ,  Tertiary & Higher Education ,  General
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

Section I Pharmacodynamic Biomarkers 1. Introduction 2. Toxicology Studies 3. Bioequivalence Studies 4. Cross-Sectional Profile of Pharmacodynamics Biomarkers 5. Timecourse Profile of Pharmacodynamics Biomarkers 6. Evaluating Multiple Biomarkers Section II Predictive Biomarkers 7. Introduction 8. Operational Characteristics of Proof-of-Concept Trials with Biomarker-Positive and -Negative Subgroups 9. A Framework for Testing Biomarker Subgroups in Confirmatory Trials 10. Cutoff Determination of Continuous Predictive Biomarker for a Biomarker–Treatment Interaction 11. Cutoff Determination of Continuous Predictive Biomarker Using Group Sequential Methodology 12. Adaptive Threshold Design 13. Adaptive Seamless Design (ASD) Section III Surrogate Endpoints 14. Introduction 15. Requirement # 1: Trial Level – Correlation Between Hazard Ratios in Progression-Free Survival and Overall Survival Across Trials 16. Requirement # 2: Individual Level – Assess the Correlation Between the Surrogate and True Endpoints After Adjusting for Treatment (R2 indiv) 17. Examining the Proportion of Treatment Effect in AIDS Clinical Trials 18. Concluding Remarks Section IV Combining Multiple Biomarkers 19. Introduction 20. Regression-Based Models 21. Tree-Based Models 22. Cluster Analysis 23. Graphical Models Section V Biomarker Statistical Analysis Plan

Reviews

I can imagine applied statisticians having a hardcover version on their desks near their computer, in a somewhat overused condition, referring to this every now and then for the implementation of the described methods in practice. Goal achieved in such a case. - Christos T. Nakas, International Society for Clinical Biostatistics, 71, 2021

Author Information

Nusrat Rabbee is a biostatistician and data scientist at Rabbee & Associates, where she creates innovative solutions to help companies accelerate drug and diagnostic development for patients. Her research interest lies in the intersection of data science and personalized medicine. She has extensive experience in bioinformatics, clinical statistics and high-dimensional data analyses. She has co-discovered the RLMM algorithm for genotyping Affymetrix SNP chips and co-invented a high-dimensional molecular signature for cancer. She has spent over 17 years in the pharmaceutical and diagnostics industry focusing on biomarker development. She has taught statistics at UC Berkeley for 4 years.

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