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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).
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).
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.
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
| Erscheinungsjahr: | 2018 |
|---|---|
| Fachbereich: | Wahrscheinlichkeitstheorie |
| Genre: | Importe, Mathematik |
| Rubrik: | Naturwissenschaften & Technik |
| Medium: | Buch |
| ISBN-13: | 9781498721400 |
| ISBN-10: | 1498721400 |
| Sprache: | Englisch |
| Einband: | Gebunden |
| 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: | 260 x 183 x 24 mm |
| Von/Mit: | Todd Coffey (u. a.) |
| Erscheinungsdatum: | 05.06.2018 |
| Gewicht: | 0,872 kg |
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.
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
| Erscheinungsjahr: | 2018 |
|---|---|
| Fachbereich: | Wahrscheinlichkeitstheorie |
| Genre: | Importe, Mathematik |
| Rubrik: | Naturwissenschaften & Technik |
| Medium: | Buch |
| ISBN-13: | 9781498721400 |
| ISBN-10: | 1498721400 |
| Sprache: | Englisch |
| Einband: | Gebunden |
| 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: | 260 x 183 x 24 mm |
| Von/Mit: | Todd Coffey (u. a.) |
| Erscheinungsdatum: | 05.06.2018 |
| Gewicht: | 0,872 kg |
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