Pharmaceutical Statistics : MBSW 39, Muncie, Indiana, USA, May 16-18, 2016. 1st ed. 2019

種類:

電子ブック

責任表示:

edited by Ray Liu, Yi Tsong

出版情報:

Cham : Springer International Publishing : Imprint: Springer, 2019

著者名:

• Liu, Ray.
• Tsong, Yi.
• SpringerLink (Online service)

シリーズ名:

Springer Proceedings in Mathematics & Statistics ; 218

ISBN:

9783319673868 [3319673866]    

注記:

Part I: Specification and Sampling Acceptance Tests -- Statistical Considerations in Setting Quality Specification Limits Using Quality Data -- Counting Test and Parametric Two One-Sided Tolerance Interval Test for Content Uniformity Using Large Sample Sizes -- Part II: Analytical Biosimilar and Process Validation -- Sample Size Consideration for Equivalent Test of Tier-1 Quality Attributes for Analytical Biosimilarity Assessment -- A Probability Based Equivalence Test of NIR Versus HPLC Analytical Methods in a Continuous Manufacturing Process Validation Study -- A Further Look at the Current Equivalence Test for Analytical Similarity Assessment -- Shiny Tools for Sample Size Calculation in Process Performance Qualification of Large Molecules -- Part III: Continuous Process -- Risk Evaluation of Registered Specifications and Internal Release Limits Using a Bayesian Approach -- Development of Statistical Computational Tools Through Pharmaceutical Drug Development and Manufacturing Life Cycle -- Application of
This book presents the proceedings of the 39th annual Midwest Biopharmaceutical Statistics Workshop (MBSW), held in Muncie, Indiana on May 16–18, 2016. It consists of selected peer- reviewed and revised papers on topics ranging from statistical applications in drug discovery and CMC to biomarkers, clinical trials, and statistical programming. All contributions feature original research, and together they cover the full spectrum of pharmaceutical R&D – with a special focus on emergent topics such as biosimilarity, bioequivalence, clinical trial design, and subgroup identification. Founded in 1978, the MBSW has provided a forum for statisticians to share knowledge, research, and applications on key statistical topics in pharmaceutical R&D for almost forty years, with the 2016 conference theme being “The Power and 3 I’s of Statistics: Innovation, Impact and Integrity.” The papers gathered here will be of interest to all researchers whose work involves the quantitative aspects of pharmaceutical research and devel

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