Design and Analysis of Subgroups with Biopharmaceutical Applications

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...

Full description

Bibliographic Details
Other Authors: Ting, Naitee (Editor), Cappelleri, Joseph C. (Editor), Ho, Shuyen (Editor), Chen, (Din) Ding-Geng (Editor)
Format: eBook
Language:English
Published: Cham Springer International Publishing 2020, 2020
Edition:1st ed. 2020
Series:Emerging Topics in Statistics and Biostatistics
Subjects:
Online Access:
Collection: Springer eBooks 2005- - Collection details see MPG.ReNa
LEADER 03333nmm a2200337 u 4500
001 EB001897647
003 EBX01000000000000001060652
005 00000000000000.0
007 cr|||||||||||||||||||||
008 200604 ||| eng
020 |a 9783030401054 
100 1 |a Ting, Naitee  |e [editor] 
245 0 0 |a Design and Analysis of Subgroups with Biopharmaceutical Applications  |h Elektronische Ressource  |c edited by Naitee Ting, Joseph C. Cappelleri, Shuyen Ho, (Din) Ding-Geng Chen 
250 |a 1st ed. 2020 
260 |a Cham  |b Springer International Publishing  |c 2020, 2020 
300 |a XVIII, 400 p. 61 illus., 43 illus. in color  |b online resource 
505 0 |a 1. Data-driven and Confirmatory Subgroup Analysis in Clinical Trials -- 2. Subgroup Analysis – A View from Industry -- 3. Biomarker-Targeted Confirmatory Trials -- 4. Considerations on Subgroup Analysis in Design and Analysis of Multi-Regional Clinical Trials -- 5. Practical Subgroup Identification Strategies in Late-stage Clinical Trials -- 6. Exploratory Subgroup Identification for Biopharmaceutical Development -- 7. Logical Inference on Treatment Efficacy When Subgroup Exists -- 8. The GUIDE Approach to Subgroup Identification and Inference -- 9. Use of the VG (Virtual Twins Combined with GUIDE) Method in the Development of Precision Medicines -- 10. Subgroups Identification for Tailored Therapies: a System of Methods, a Framework for Consistent Methodology Evaluation, and an Integrated Learn-and-confirm Approach -- 11. Developing and Validating Predictive Classifiers in Randomized Clinical Trials -- 12. Issues Related to Subgroup Analysis -- 13. Subgroup Analysis with Partial Linear Model -- 14. Subgroup Analysis in the 21st Century -- 15. Power of Statistical Tests for Subgroup Analysis in Meta-Analysis -- 16. Heterogeneity and Subgroup Analysis in Network Meta-Analysis 
653 |a Pharmaceutical chemistry 
653 |a Biostatistics 
653 |a Pharmaceutics 
653 |a Biometry 
700 1 |a Cappelleri, Joseph C.  |e [editor] 
700 1 |a Ho, Shuyen  |e [editor] 
700 1 |a Chen, (Din) Ding-Geng  |e [editor] 
041 0 7 |a eng  |2 ISO 639-2 
989 |b Springer  |a Springer eBooks 2005- 
490 0 |a Emerging Topics in Statistics and Biostatistics 
028 5 0 |a 10.1007/978-3-030-40105-4 
856 4 0 |u https://doi.org/10.1007/978-3-030-40105-4?nosfx=y  |x Verlag  |3 Volltext 
082 0 |a 570.15195 
520 |a 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 statistical and methodological developments, and potential future directions. The volume covers topics in subgroups in clinical trial design; subgroup identification and personalized medicine; and general issues in subgroup analyses, including regulatory ones. Included chapters present current methods, theories, and case applications in the diverse field of subgroup application and analysis. Offering timely perspectives from a range of authoritative sources, the volume is designed to have wide appeal to professionals in the pharmaceutical industry and to graduate students and researchers in academe and government