Pharmaceutical Statistics MBSW 39, Muncie, Indiana, USA, May 16-18, 2016 /
This book presents the proceedings of the 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW), held in Muncie, Indiana on May 16-18, 2016. It consists of selected peer- reviewed and revised papers on topics ranging from statistical applications in drug discovery and CMC to biomarkers, c...
| Συγγραφή απο Οργανισμό/Αρχή: | |
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| Άλλοι συγγραφείς: | , |
| Μορφή: | Ηλεκτρονική πηγή Ηλ. βιβλίο |
| Γλώσσα: | English |
| Έκδοση: |
Cham :
Springer International Publishing : Imprint: Springer,
2019.
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| Έκδοση: | 1st ed. 2019. |
| Σειρά: | Springer Proceedings in Mathematics & Statistics,
218 |
| Θέματα: | |
| Διαθέσιμο Online: | Full Text via HEAL-Link |
Πίνακας περιεχομένων:
- Part I: Specification and Sampling Acceptance Tests
- Statistical Considerations in Setting Quality Specification Limits Using Quality Data
- Counting Test and Parametric Two One-Sided Tolerance Interval Test for Content Uniformity Using Large Sample Sizes
- Part II: Analytical Biosimilar and Process Validation
- Sample Size Consideration for Equivalent Test of Tier-1 Quality Attributes for Analytical Biosimilarity Assessment
- A Probability Based Equivalence Test of NIR Versus HPLC Analytical Methods in a Continuous Manufacturing Process Validation Study
- A Further Look at the Current Equivalence Test for Analytical Similarity Assessment
- Shiny Tools for Sample Size Calculation in Process Performance Qualification of Large Molecules
- Part III: Continuous Process
- Risk Evaluation of Registered Specifications and Internal Release Limits Using a Bayesian Approach
- Development of Statistical Computational Tools Through Pharmaceutical Drug Development and Manufacturing Life Cycle
- 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 Approach
- Part IV: Clinical Trial Design and Analysis
- Exact Inference for Adaptive Group Sequential Designs
- A Novel Framework for Bayesian Response-Adaptive Randomization
- Sample Size Determination Under Non-proportional Hazards
- Adaptive Three-Stage Clinical Trial Design for a Binary Endpoint in the Rare Disease Setting
- Part V: Biomarker-Driven Trial Design
- Clinical Trial Designs to Evaluate Predictive Biomarkers: What's Being Estimated?
- Biomarker Enrichment Design Considerations in Oncology Single Arm Studies
- Challenges of Bridging Studies in Biomarker Driven Clinical Trials: The Impact of Companion Diagnostic Device Performance on Clinical Efficacy
- Part VI: Application of Novel Data Modality
- Parallel-Tempered Feature Allocation for Large-Scale Tumor Heterogeneity with Deep Sequencing Data
- Analysis of T-Cell Immune Responses as Measured by Intracellular Cytokine Staining with Application to Vaccine Clinical Trials
- Project Data Sphere and the Applications of Historical Patient Level Clinical Trial Data in Oncology Drug Development
- Novel Test for the Equality of Continuous Curves with Homoscedastic or Heteroscedastic Measurement Errors
- Quality Control Metrics for Extraction-Free Targeted RNA-Seq Under a Compositional Framework
- Part VII: Omics Data Analysis
- Leveraging Omics Biomarker Data in Drug Development: With a GWAS Case Study
- A Simulation Study Comparing SNP Based Prediction Models of Drug Response.
