Development of Statistical Computational Tools Through Pharmaceutical Drug Development and Manufacturing Life Cycle (English)
- New search for: Li, Fasheng
- New search for: Wang, Ke
- New search for: Li, Fasheng
- New search for: Wang, Ke
In:
Pharmaceutical Statistics
3
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101-111
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2019
- Article/Chapter (Book) / Electronic Resource
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Title:Development of Statistical Computational Tools Through Pharmaceutical Drug Development and Manufacturing Life Cycle
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Contributors:Li, Fasheng ( author ) / Wang, Ke ( author )
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Published in:Pharmaceutical Statistics , 3 ; 101-111Springer Proceedings in Mathematics & Statistics ; 218, 3 ; 101-111
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Publisher:
- New search for: Springer International Publishing
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Place of publication:Cham
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Publication date:2019-01-01
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Size:11 pages
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ISBN:
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ISSN:
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DOI:
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Type of media:Article/Chapter (Book)
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Type of material:Electronic Resource
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Language:English
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Keywords:
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Source:
Table of contents eBook
The tables of contents are generated automatically and are based on the data records of the individual contributions available in the index of the TIB portal. The display of the Tables of Contents may therefore be incomplete.
- 3
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Statistical Considerations in Setting Quality Specification Limits Using Quality DataTsong, Yi / Wang, Tianhua / Hu, Xin et al. | 2019
- 13
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Counting Test and Parametric Two One-Sided Tolerance Interval Test for Content Uniformity Using Large Sample SizesShen, Meiyu / Tsong, Yi / Lostritto, Richard et al. | 2019
- 27
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Sample Size Consideration for Equivalent Test of Tier-1 Quality Attributes for Analytical Biosimilarity AssessmentWang, Tianhua / Tsong, Yi / Shen, Meiyu et al. | 2019
- 45
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A Probability Based Equivalence Test of NIR Versus HPLC Analytical Methods in a Continuous Manufacturing Process Validation StudyManola, Areti / Novick, Steven / Shoung, Jyh-Ming / Altan, Stan et al. | 2019
- 55
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A Further Look at the Current Equivalence Test for Analytical Similarity AssessmentThomas, Neal / Cheng, Aili et al. | 2019
- 71
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Shiny Tools for Sample Size Calculation in Process Performance Qualification of Large MoleculesLi, Qianqiu / Pikounis, Bill et al. | 2019
- 89
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Risk Evaluation of Registered Specifications and Internal Release Limits Using a Bayesian ApproachDong, Yijie / Wang, Tianhua et al. | 2019
- 101
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Development of Statistical Computational Tools Through Pharmaceutical Drug Development and Manufacturing Life CycleLi, Fasheng / Wang, Ke et al. | 2019
- 113
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Application of Advanced Statistical Tools to Achieve Continuous Analytical Verification: A Risk Assessment Case of the Impact of Analytical Method Performance on Process Performance Using a Bayesian ApproachYan, Iris / Dong, Yijie et al. | 2019
- 131
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Exact Inference for Adaptive Group Sequential DesignsMehta, Cyrus / Liu, Lingyun / Ghosh, Pranab / Gao, Ping et al. | 2019
- 141
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A Novel Framework for Bayesian Response-Adaptive RandomizationZhu, Jian / Jazić, Ina / Liu, Yi et al. | 2019
- 157
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Sample Size Determination Under Non-proportional HazardsYang, Miao / Hua, Zhaowei / Vardhanabhuti, Saran et al. | 2019
- 167
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Adaptive Three-Stage Clinical Trial Design for a Binary Endpoint in the Rare Disease SettingGan, Lingrui / Hua, Zhaowei et al. | 2019
- 183
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Clinical Trial Designs to Evaluate Predictive Biomarkers: What’s Being Estimated?Pennello, Gene / Ye, Jingjing et al. | 2019
- 203
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Biomarker Enrichment Design Considerations in Oncology Single Arm StudiesTian, Hong / Liu, Kevin et al. | 2019
- 215
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Challenges of Bridging Studies in Biomarker Driven Clinical Trials: The Impact of Companion Diagnostic Device Performance on Clinical EfficacyTang, Szu-Yu / LaFleur, Bonnie et al. | 2019
- 233
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Parallel-Tempered Feature Allocation for Large-Scale Tumor Heterogeneity with Deep Sequencing DataNi, Yang / Müller, Peter / Shpak, Max / Ji, Yuan et al. | 2019
- 249
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Analysis of T-Cell Immune Responses as Measured by Intracellular Cytokine Staining with Application to Vaccine Clinical TrialsLin, Yunzhi / Han, Cong et al. | 2019
- 263
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Project Data Sphere and the Applications of Historical Patient Level Clinical Trial Data in Oncology Drug DevelopmentHather, Greg / Liu, Ray et al. | 2019
- 273
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Novel Test for the Equality of Continuous Curves with Homoscedastic or Heteroscedastic Measurement ErrorsZhang, Zhongfa / Yang, Yarong / Sun, Jiayang et al. | 2019
- 299
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Quality Control Metrics for Extraction-Free Targeted RNA-Seq Under a Compositional FrameworkLaRoche, Dominic / Billheimer, Dean / Michels, Kurt / LaFleur, Bonnie et al. | 2019
- 317
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Leveraging Omics Biomarker Data in Drug Development: With a GWAS Case StudyZhang, Weidong et al. | 2019
- 327
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A Simulation Study Comparing SNP Based Prediction Models of Drug ResponseZhang, Wencan / Zhang, Pingye / Gao, Feng / Zhu, Yonghong / Liu, Ray et al. | 2019