Case Studies in Bayesian Methods for Biopharmaceutical CMC
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Case Studies in Bayesian Methods for Biopharmaceutical CMC
Pourmohamad, Tony; Faya, Paul
Taylor & Francis Ltd
12/2022
340
Dura
Inglês
9781032185484
15 a 20 dias
Descrição não disponível.
1. Introduction 2. An Overview of Bayesian Computation 3. Basic Bayesian Model Checking 4. Quantitative Decision - Making, a CMC application to analytical method equivalence 5. Bayesian Dissolution Testing 6. A Non-Normal Bayesian Model for the Estimation and Comparison of Immunogenicity Screening Assay Cut-Points 7. Application of Bayesian Hierarchical Models to Experimental Design 8. Bayesian Prediction for Staged Testing Procedures 9. A Bayesian Approach to Multivariate Conditional Regression Surrogate Modeling with Application to Real Time Release Testing 10. Bayesian Approach for Demonstrating Analytical Similarity 11. Bayesian Evaluation and Monitoring of Process Comparability 12. Bayesian Alternatives to Traditional Methods for Estimating Product Shelf Life and Internal Release Limits 13. Application of Bayesian Methods for Specification Setting 14. Calculating Statistical Tolerance Intervals Using SAS 15. A Bayesian Application in Process Monitoring - Establishing Limits for Dosage Units in Early Phase Process Control
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Bayesian Statistics;Biostatistics;Bayesian Computation;Chemistry, manufacturing and control;Biopharmaceutical;Experimental design;Statistical Tolerance Intervals;Process Monitoring;Bayesian Modelling;Quantitative Decision Making;Posterior Probability;Posterior Distribution;Posterior Predictive Distribution;Posterior Samples;Credible Interval;Trace Plots;Parametric Tolerance Interval;Hamiltonian Monte Carlo;Tolerance Interval;Ich Q1E;Dissolution Profile;Non-informative Priors;Mixed Effects Model;UTL;Historical Batches;Prior Distributions;CP Estimation;Posterior Density Plots;Prior Predictive Distribution;Method Variability;Posterior Predictive Samples;Future Batch;API Content;Dissolution Testing;REML Estimate
1. Introduction 2. An Overview of Bayesian Computation 3. Basic Bayesian Model Checking 4. Quantitative Decision - Making, a CMC application to analytical method equivalence 5. Bayesian Dissolution Testing 6. A Non-Normal Bayesian Model for the Estimation and Comparison of Immunogenicity Screening Assay Cut-Points 7. Application of Bayesian Hierarchical Models to Experimental Design 8. Bayesian Prediction for Staged Testing Procedures 9. A Bayesian Approach to Multivariate Conditional Regression Surrogate Modeling with Application to Real Time Release Testing 10. Bayesian Approach for Demonstrating Analytical Similarity 11. Bayesian Evaluation and Monitoring of Process Comparability 12. Bayesian Alternatives to Traditional Methods for Estimating Product Shelf Life and Internal Release Limits 13. Application of Bayesian Methods for Specification Setting 14. Calculating Statistical Tolerance Intervals Using SAS 15. A Bayesian Application in Process Monitoring - Establishing Limits for Dosage Units in Early Phase Process Control
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Bayesian Statistics;Biostatistics;Bayesian Computation;Chemistry, manufacturing and control;Biopharmaceutical;Experimental design;Statistical Tolerance Intervals;Process Monitoring;Bayesian Modelling;Quantitative Decision Making;Posterior Probability;Posterior Distribution;Posterior Predictive Distribution;Posterior Samples;Credible Interval;Trace Plots;Parametric Tolerance Interval;Hamiltonian Monte Carlo;Tolerance Interval;Ich Q1E;Dissolution Profile;Non-informative Priors;Mixed Effects Model;UTL;Historical Batches;Prior Distributions;CP Estimation;Posterior Density Plots;Prior Predictive Distribution;Method Variability;Posterior Predictive Samples;Future Batch;API Content;Dissolution Testing;REML Estimate
