Statistics for Biotechnology Process Development

ISBN-13: 9780367657222 / Angielski / Miękka / 2020 / 346 str.

Todd Coffey; Harry Yang

Opis

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).

Spis treści

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

O autorze

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.