
Statistics for Biotechnology Process Development
Description
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Provides an introduction to the statistical concepts important in the biotechnology industry
Focuses on concepts with theoretical details kept to a minimum
Includes lots of real examples and case studies to illustrate the methods
Uses JMP software for implementation of the methods
Offers a text suitable for scientists in the industry with some quantitative training
Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.
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Content
Design of Experiments (DOE) for Process Development -Todd Coffey
Quality by Design Applied in Formulation Development and Robustness -Pierre Lebrun, Perceval Sondag, Xavier Lories, Jean-Francois Michiels, Eric Rozet, and Bruno Boulanger
Analytical Procedure Development and Qualification -Rick Burdick
Strategic Bioassay Design, Development, Analysis, and Validation -David Lansky
Setting Specifications -Harry Yang
Statistical Analysis of Stability Studies -Laura Pack
Continued Process Verification - Tara Scherder, Katherine Giacoletti
Multivariate Analysis for Bioprocess Understanding and Troubleshooting - Jianchun Zhang and Harry Yang
Assessment of analytical method robustness: statistical versus practical significance -Binbing Yu, Lingmin Zeng, and Harry Yang
cGMP Sampling - Harry Yang
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