Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics
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9783319673851, 9783319673868

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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 ◽

Biomarker Data

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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 ◽

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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Springer Proceedings in Mathematics & Statistics - Pharmaceutical StatisticsLatest Publications

TOTAL DOCUMENTS

H-INDEX

Published By Springer International Publishing

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

A Simulation Study Comparing SNP Based Prediction Models of Drug Response

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

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

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

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

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

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

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

Biomarker Enrichment Design Considerations in Oncology Single Arm Studies

Springer Proceedings in Mathematics & Statistics - Pharmaceutical Statistics
Latest Publications