Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC).
Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC).Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.
Todd Coffey (PhD Biostatistics) is the founding chair and an associate professor in the Department of Research and Biostatistics at the Idaho College of Osteopathic Medicine. Previously, he started a university-wide statistical consulting center at Washington State University and spend a decade in the biotechnology industry as a nonclinical statistician, making major contributions to successful worldwide regulatory submissions for multiple innovator biologics.
Inhaltsangabe
Interpretation and Treatment of Data - Harry Yang, Steven J. Novick, and Lorin Roskos 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-François 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
Interpretation and Treatment of Data - Harry Yang, Steven J. Novick, and Lorin Roskos 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-François 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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