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Book Cover
E-book
Author Faya, Paul

Title Case Studies in Bayesian Methods for Biopharmaceutical CMC
Published Milton : CRC Press LLC, 2022

Copies

Description 1 online resource (354 p.)
Series Chapman and Hall/CRC Biostatistics Ser
Chapman and Hall/CRC Biostatistics Ser
Contents Cover -- Half Title -- Series Page -- Title Page -- Copyright Page -- Dedication -- Contents -- Foreword -- Preface -- Contributors -- 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 -- Bibliography
Notes Description based upon print version of record
Form Electronic book
Author Pourmohamad, Tony
ISBN 9781000824865
1000824861