Statistics for Biotechnology Process Devel...

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Sprache: Englisch

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Beschreibung

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).

Über den Autor

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.

Inhaltsverzeichnis

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

Details

Erscheinungsjahr:	2020
Fachbereich:	Wahrscheinlichkeitstheorie
Genre:	Importe , Mathematik
Rubrik:	Naturwissenschaften & Technik
Medium:	Taschenbuch
ISBN-13:	9780367657222
ISBN-10:	0367657228
Sprache:	Englisch
Einband:	Kartoniert / Broschiert
Redaktion:	Coffey, Todd Yang, Harry
Hersteller:	Chapman and Hall/CRC
Verantwortliche Person für die EU:	Libri GmbH, Europaallee 1, D-36244 Bad Hersfeld, gpsr@libri.de
Maße:	254 x 178 x 19 mm
Von/Mit:	Todd Coffey (u. a.)
Erscheinungsdatum:	30.09.2020
Gewicht:	0,677 kg