Statistics for Biotechnology Process Development
Editat de Todd Coffey, Harry Yangen Limba Engleză Hardback – 5 iun 2018
- 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
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Specificații
ISBN-13: 9781498721400
ISBN-10: 1498721400
Pagini: 358
Ilustrații: 154 Line drawings, black and white; 23 Halftones, black and white; 72 Tables, black and white; 177 Illustrations, black and white
Dimensiuni: 178 x 254 x 21 mm
Greutate: 0.68 kg
Ediția:1
Editura: CRC Press
Colecția Chapman and Hall/CRC
ISBN-10: 1498721400
Pagini: 358
Ilustrații: 154 Line drawings, black and white; 23 Halftones, black and white; 72 Tables, black and white; 177 Illustrations, black and white
Dimensiuni: 178 x 254 x 21 mm
Greutate: 0.68 kg
Ediția:1
Editura: CRC Press
Colecția Chapman and Hall/CRC
Cuprins
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
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
Notă biografică
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.
Descriere
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).