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Bücher Englische Bücher Wissen & Bildung Naturwissenschaft, Medizin, Informatik, Technik Mathematik Wahrscheinlichkeitstheorie & Statistik Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
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Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang (Gebundene Ausgabe, Englisch)
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Beschreibung
This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic… statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples. Dieses Produkt haben wir gerade leider nicht auf Lager.
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Technische Daten
Erscheinungsdatum
22.02.2017
Sprache
Englisch
EAN
9783319501840
Herausgeber
Springer International Publishing
Serien- oder Bandtitel
Statistics for Biology and Health
Sonderedition
Nein
Autor
Richard K. Burdick, David J. LeBlond, Lori B. Pfahler, Jorge Quiroz, Leslie Sidor, Kimberly Vukovinsky, Lanju Zhang
Seitenanzahl
379
Auflage
1
Einbandart
Gebundene Ausgabe
Schlagwörter
Analytical Methods, Biosimilarity, CMC Statistics, Chemistry, Manufacturing and Controls, FDA Guidance, Pharmaceutical Manufacturing, Process Verification, Quality by Design, Stability Studies
Thema-Inhalt
PBT - Wahrscheinlichkeitsrechnung und Statistik
PNB - Medizinische Chemie, Pharmazeutische Chemie
MQP - Pharmazie, Apotheke
Höhe
235 mm
Breite
15.5 cm
Hersteller: Springer, Europaplatz 3, Heidelberg, Deutschland, 69115, ProductSafety@springernature.com, Springer Nature Customer Service Center GmbH
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