Pharmaceutical Statistics

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 Heterogeneitywith 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.

Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.

• Probabilidade e Estatística
• Bioquímica

pharmaceutical statistics;clinical trial;CMC;biomarker;subgroup analysis;biosimilarity