Design and analysis of subgroups with biopharmaceutical applications

Design and analysis of subgroups with biopharmaceutical applications / Naitee Ting, Joseph C. Cappelleri, Shuyen Ho, (Din) Ding-Geng Chen, editors.

This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry. Drawing from a range of expert perspectives in academia and industry, this collection offers an overarching dialogue about recent advances in biopharmaceutical applications, novel statisti...

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Bibliographic Details
Other Authors: Ting, Naitee, Cappelleri, Joseph C., Ho, Shuyen, Chen, Ding-Geng
Format: eBook
Language:English
Published: Cham : Springer, 2020.
Series:Emerging topics in statistics and biostatistics.
Subjects:
Drugs > Testing > Statistical methods.
Biopharmaceutics.
Life sciences: general issues.
Pharmaceutical technology.
Probability & statistics.
Science > Life Sciences > General.
Medical > Pharmacy.
Medical > Biostatistics.
Biopharmaceutics
Drugs > Testing > Statistical methods
Electronic books.
Online Access:Click for online access
Table of Contents:
  • Part I. Subgroups in Clinical Trial Design and Analysis
  • Issues Related to Subgroup Analyses and Use of Intensive Stratification
  • Biomarker-Targeted Confirmatory Trials
  • Data-Driven and Confirmatory Subgroup Analysis in Clinical Trials
  • Considerations on Subgroup Analysis in Design and Analysis of Multi-Regional Clinical Trials
  • Part II. Subgroup Identification and Personalized Medicine
  • Practical Subgroup Identification Strategies in Late-Stage Clinical Trials
  • The GUIDE Approach to Subgroup Identification
  • A Novel Method of Subgroup Identification by Combining Virtual Twins with GUIDE (VG) for Development of Precision Medicines
  • Subgroup Identification for Tailored Therapies: Methods and Consistent Evaluation
  • A New Paradigm for Subset Analysis in Randomized Clinical Trials
  • Logical Inference on Treatment Efficacy When Subgroups Exist
  • Subgroup Analysis with Partial Linear Regression Model
  • Exploratory Subgroup Identification for Biopharmaceutical Development
  • Statistical Learning Methods for Optimizing Dynamic Treatment Regimes in Subgroup Identification
  • Part III. General Issues About Subgroup Analysis, Including Regulatory Considerations
  • Subgroups in Design and Analysis of Clinical Trials, General Considerations
  • Subgroup Analysis: A View from Industry
  • Subgroup Analysis from Bayesian Perspectives
  • Power of Statistical Tests for Subgroup Analysis in Meta-Analysis
  • Heterogeneity and Subgroup Analysis in Network Meta-Analysis.

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