Case Studies in Bayesian Methods for Biopharmaceutical CMC

图书简介

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. • First book of its kind focusing strictly on CMC Bayesian case studies • Case studies with code and output • Representation from several companies across the industry as well as academia• Authors are leading and well-known Bayesian statisticians in the CMC field • Accompanying website with code for reproducibility • Reflective of real-life industry applications/problems

1. Introduction Paul Faya and Tony Pourmohamad 2. An Overview of Bayesian Computation David J. Kahle, John W. Seaman Jr., and James D. Stamey 3. Basic Bayesian Model CheckingJohn W. Seaman Jr., David J. Kahle, and James D. Stamey4. Quantitative Decision - Making, a CMC application to analytical method equivalence Misbah Ahmed and Mike Denham 5. Bayesian Dissolution Testing Tony Pourmohamad and Robert Richardson 6. 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 Zeng7. Application of Bayesian Hierarchical Models to Experimental Design Adam P. Rauk and Paul Faya 8. Bayesian Prediction for Staged Testing Procedures Katherine E.D. Giacoletti and Tara Scherder 9. 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 Schmid10. Bayesian Approach for Demonstrating Analytical Similarity Harry Yang and Steven Novick 11. Bayesian Evaluation and Monitoring of Process ComparabilityKe Wang and Aili Cheng12. Bayesian Alternatives to Traditional Methods for Estimating Product Shelf Life and Internal Release Limits Perceval Sondag, Ji Young Kim, Laurent Natalis, and Tara Scherder 13. Application of Bayesian Methods for Specification Setting Chris Thompson and Guillermo Miro-Quesada14. Calculating Statistical Tolerance Intervals Using SAS Richard Lewis and Buffy Hudson-Curtis 15. A Bayesian Application in Process Monitoring – Establishing Limits for Dosage Units in Early Phase Process Control

Trade Policy 买家须知

关于产品：
● 正版保障：本网站隶属于中国国际图书贸易集团公司，确保所有图书都是100%正版。
● 环保纸张：进口图书大多使用的都是环保轻型张，颜色偏黄，重量比较轻。
● 毛边版：即书翻页的地方，故意做成了参差不齐的样子，一般为精装版，更具收藏价值。
关于退换货：
由于预订产品的特殊性，采购订单正式发订后，买方不得无故取消全部或部分产品的订购。
由于进口图书的特殊性，发生以下情况的，请直接拒收货物，由快递返回：
● 外包装破损/发错货/少发货/图书外观破损/图书配件不全（例如：光盘等）
并请在工作日通过电话400-008-1110联系我们。
签收后，如发生以下情况，请在签收后的5个工作日内联系客服办理退换货：
● 缺页/错页/错印/脱线
关于发货时间：
一般情况下：
●【现货】下单后48小时内由北京（库房）发出快递。
●【预订】【预售】下单后国外发货，到货时间预计5-8周左右，店铺默认中通快递，如需顺丰快递邮费到付。
● 需要开具发票的客户，发货时间可能在上述基础上再延后1-2个工作日（紧急发票需求，请联系010-68433105/3213）；
● 如遇其他特殊原因，对发货时间有影响的，我们会第一时间在网站公告，敬请留意。
关于到货时间：
由于进口图书入境入库后，都是委托第三方快递发货，所以我们只能保证在规定时间内发出，但无法为您保证确切的到货时间。
● 主要城市一般2-4天
● 偏远地区一般4-7天
关于接听咨询电话的时间：
010-68433105/3213正常接听咨询电话的时间为：周一至周五上午8：30～下午5：00，周六、日及法定节假日休息，将无法接听来电，敬请谅解。
其它时间您也可以通过邮件联系我们：customer@readgo.cn,工作日会优先处理。
关于快递：
● 已付款订单：主要由中通、宅急送负责派送，订单进度查询请拨打010-68433105/3213。

Case Studies in Bayesian Methods for Biopharmaceutical CMC（Chapman ） 生物制药 CMC 的贝叶斯方法案例研究 生物数学

Case Studies in Bayesian Methods for Biopharmaceutical CMC（Chapman ）

生物制药 CMC 的贝叶斯方法案例研究
生物数学