Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics
Latest Publications

TOTAL DOCUMENTS

23

(FIVE YEARS 23)

H-INDEX

1

(FIVE YEARS 1)

Published By Springer International Publishing

9783319673851, 9783319673868

Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords

Risk Evaluation of Registered Specifications and Internal Release Limits Using a Bayesian Approach

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics ◽

10.1007/978-3-319-67386-8_7 ◽

2019 ◽

pp. 89-99

Author(s):

Yijie Dong ◽

Tianhua Wang

Keyword(s):

Bayesian Approach ◽

Risk Evaluation ◽

Release Limits ◽

Internal Release

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A Simulation Study Comparing SNP Based Prediction Models of Drug Response

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics ◽

10.1007/978-3-319-67386-8_23 ◽

2019 ◽

pp. 327-337

Author(s):

Wencan Zhang ◽

Pingye Zhang ◽

Feng Gao ◽

Yonghong Zhu ◽

Ray Liu

Keyword(s):

Simulation Study ◽

Drug Response ◽

Prediction Models

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Leveraging Omics Biomarker Data in Drug Development: With a GWAS Case Study

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics ◽

10.1007/978-3-319-67386-8_22 ◽

2019 ◽

pp. 317-325

Author(s):

Weidong Zhang

Keyword(s):

Drug Development ◽

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Project Data Sphere and the Applications of Historical Patient Level Clinical Trial Data in Oncology Drug Development

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics ◽

10.1007/978-3-319-67386-8_19 ◽

2019 ◽

pp. 263-272

Author(s):

Greg Hather ◽

Ray Liu

Keyword(s):

Clinical Trial ◽

Drug Development ◽

Clinical Trial Data ◽

Patient Level ◽

Oncology Drug ◽

Project Data ◽

Oncology Drug Development

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Adaptive Three-Stage Clinical Trial Design for a Binary Endpoint in the Rare Disease Setting

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics ◽

10.1007/978-3-319-67386-8_13 ◽

2019 ◽

pp. 167-180

Author(s):

Lingrui Gan ◽

Zhaowei Hua

Keyword(s):

Clinical Trial ◽

Rare Disease ◽

Trial Design ◽

Clinical Trial Design

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Shiny Tools for Sample Size Calculation in Process Performance Qualification of Large Molecules

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics ◽

10.1007/978-3-319-67386-8_6 ◽

2019 ◽

pp. 71-86

Author(s):

Qianqiu Li ◽

Bill Pikounis

Keyword(s):

Sample Size ◽

Sample Size Calculation ◽

Process Performance ◽

Large Molecules ◽

Performance Qualification ◽

Process Performance Qualification

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A Further Look at the Current Equivalence Test for Analytical Similarity Assessment

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics ◽

10.1007/978-3-319-67386-8_5 ◽

2019 ◽

pp. 55-70

Author(s):

Neal Thomas ◽

Aili Cheng

Keyword(s):

Equivalence Test ◽

Similarity Assessment

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A Probability Based Equivalence Test of NIR Versus HPLC Analytical Methods in a Continuous Manufacturing Process Validation Study

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics ◽

10.1007/978-3-319-67386-8_4 ◽

2019 ◽

pp. 45-54

Author(s):

Areti Manola ◽

Steven Novick ◽

Jyh-Ming Shoung ◽

Stan Altan

Keyword(s):

Validation Study ◽

Analytical Methods ◽

Manufacturing Process ◽

Continuous Manufacturing ◽

Equivalence Test ◽

Process Validation

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Analysis of T-Cell Immune Responses as Measured by Intracellular Cytokine Staining with Application to Vaccine Clinical Trials

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics ◽

10.1007/978-3-319-67386-8_18 ◽

2019 ◽

pp. 249-262

Author(s):

Yunzhi Lin ◽

Cong Han

Keyword(s):

Clinical Trials ◽

T Cell ◽

Immune Responses ◽

Intracellular Cytokine Staining ◽

Intracellular Cytokine ◽

T Cell Immune Responses

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Biomarker Enrichment Design Considerations in Oncology Single Arm Studies

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics ◽

10.1007/978-3-319-67386-8_15 ◽

2019 ◽

pp. 203-214

Author(s):

Hong Tian ◽

Kevin Liu

Keyword(s):

Design Considerations ◽

Enrichment Design

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