制药CMC 贝叶斯统计案例分析.pdfVIP

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CaseStudiesin

BayesianMethodsfor

BiopharmaceuticalCMC

ThesubjectofthisbookisappliedBayesianmethodsforchemistry,manufactur-

ing,andcontrol(CMC)studiesinthebiopharmaceuticalindustry.Thebookhas

multipleauthorsfromindustryandacademia,eachcontributingacasestudy

(chapter).ThecollectionofcasestudiescoversabroadarrayofCMCtopics,in-

cludingstabilityanalysis,analyticalmethoddevelopment,specificationsetting,

processdevelopmentandoptimization,processcontrol,experimentaldesi

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