Statistics for Biotechnology Process Development (eBook, PDF)

Redaktion: Coffey, Todd; Yang, Harry

• Format: PDF

Produktbeschreibung

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).

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 358
• Erscheinungstermin: 16. Mai 2018
• Englisch
• ISBN-13: 9781498721417
• Artikelnr.: 56838418

Autorenporträt

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