Muutke küpsiste eelistusi

E-raamat: Statistics for Biotechnology Process Development [Taylor & Francis e-raamat]

Edited by (MedImmune, LLC, Gaithersburg, Maryland, USA), Edited by (Seattle Genetics, Inc., Bothell, WA, USA)
  • Formaat: 346 pages
  • Ilmumisaeg: 30-Sep-2020
  • Kirjastus: Chapman & Hall/CRC
  • ISBN-13: 9781315120034
  • Taylor & Francis e-raamat
  • Hind: 170,80 €*
  • * hind, mis tagab piiramatu üheaegsete kasutajate arvuga ligipääsu piiramatuks ajaks
  • Tavahind: 244,00 €
  • Säästad 30%
  • Formaat: 346 pages
  • Ilmumisaeg: 30-Sep-2020
  • Kirjastus: Chapman & Hall/CRC
  • ISBN-13: 9781315120034
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). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who dont have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments.



















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.
Preface vii
Editors ix
Contributors xi
1 Interpretation and Treatment of Data
1(38)
Harry Yang
Steven J. Novick
Lorin Roskos
2 Design of Experiments (DOE) for Process Development
39(38)
Todd Coffey
3 Quality by Design Applied in Formulation Development and Robustness
77(16)
Pierre Lebrun
Perceval Sondag
Xavier Lories
Jean-Francois Michiels
Eric Rozet
Bruno Boulanger
4 Analytical Procedure Development and Qualification
93(26)
Richard K. Burdick
5 Strategic Bioassay Design, Development, Analysis, and Validation
119(26)
David Lansky
6 Setting Specification
145(24)
Harry Yang
7 Statistical Analysis of Stability Studies
169(84)
Laura D. Pack
8 Continued Process Verification
253(20)
Tara Scherder
Katherine Giacoletti
9 Multivariate Analysis for Bioprocess Understanding and Troubleshooting
273(24)
Jianchun Zhang
Harry Yang
10 Assessment of Analytical Method Robustness: Statistical versus Practical Significance
297(12)
Binbing Yu
Lingmin Zeng
Harry Yang
11 cGMP Sampling
309(22)
Harry Yang
Index 331
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.