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Case Studies in Bayesian Methods for Biopharmaceutical CMC

Case Studies in Bayesian Methods for Biopharmaceutical CMC

Hardcover

Series: Chapman & Hall/CRC Biostatistics

Medical ReferenceProbability & Statistics

Currently unavailable to order

ISBN10: 1032185481
ISBN13: 9781032185484
Publisher: Crc Pr Inc
Published: Dec 15 2022
Pages: 340
Language: English

The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). 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.

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