Case studies in Bayesian methods for biopharmaceutical CMC / edited by Paul Faya, Tony Pourmohamad.
| Other author | Faya, Paul. |
| Other author | Pourmohamad, Tony. |
| Format | Electronic |
| Edition | First edition. |
| Publication Info | Boca Raton : CRC Press, Taylor & Francis Group, 2023. |
| Description | 1 online resource |
| Supplemental Content | Full text available from Taylor & Francis eBooks |
| Subjects |
| Series | Chapman & Hall/CRC Biostatistics Series |
| Contents | An overview of Bayesian computation / David J. Kahle, John W. Seaman Jr., and James D. Stamey -- Basic Bayesian model checking / John W. Seaman Jr., David J. Kahle, and James D. Stamey -- Quantitative decision : making, a CMC application to analytical method equivalence / Misbah Ahmed and Mike Denham -- Bayesian dissolution testing / Tony Pourmohamad and Robert Richardson -- A non-normal bayesian model for the estimation and comparison of immunogenicity screening assay cut-points / David LeBlond and Robert Singer, Lu Xu, and Rong Zeng -- Application of Bayesian hierarchical models to experimental design / Adam P. Rauk and Paul Faya -- Bayesian prediction for staged testing procedures / Katherine E.D. Giacoletti and Tara Scherder -- A Bayesian approach to multivariate conditional regression surrogate modeling with application to real time release testing / Stan Altan, Dwaine Banton, Hans Coppenolle, Martin Kovarik and Martin Otava, and Christian Schmid -- Bayesian approach for demonstrating analytical similarity / Harry Yang and Steven Novick -- Bayesian evaluation and monitoring of process comparability / Ke Wang and Aili Cheng -- Bayesian alternatives to traditional methods for estimating product shelf life and internal release limits / Perceval Sondag, Ji Young Kim, Laurent Natalis, and Tara Scherder -- Application of Bayesian methods for specification setting / Chris Thompson and Guillermo Miro-Quesada -- Calculating statistical tolerance intervals using SAS / Richard Lewis and Buffy Hudson-Curtis -- A Bayesian application in process monitoring : establishing limits for dosage units in early phase process control / Yanbing Zheng, James Reynolds, Man Tang, Mark Johnson and Hesham Fahmy. |
| Abstract | "The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics"-- Provided by publisher. |
| Bibliography note | Includes bibliographical references. |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Source of description | Description based on print version record and CIP data provided by publisher. |
| Issued in other form | Print version: Case studies in Bayesian methods for biopharmaceutical CMC First edition. Boca Raton : CRC Press, Taylor & Francis Group, 2023 9781032185484 |
| Genre/form | Electronic books. |
| LCCN | 2022033958 |
| ISBN | 9781003255093 (ebook) |
| ISBN | (hardback) |
| ISBN | (paperback) |