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Statistics in Drug Research: Methodologies and Recent Developments (Biostatistics, 10) - Hardcover

Chow, Shein-Chung; Shao, Jun

 
9780824707637: Statistics in Drug Research: Methodologies and Recent Developments (Biostatistics, 10)
Hardcover
ISBN 10: 082470763X ISBN 13: 9780824707637
Verlag: CRC Press, 2019

Inhaltsangabe

Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials.

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Über die Autorin bzw. den Autor

Chow, Shein-Chung; Shao, Jun

Von der hinteren Coverseite

Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials.

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Verlag
CRC Press
Erscheinungsdatum
2019
Sprache
Englisch
ISBN 10 
082470763X
ISBN 13 
9780824707637
Einband
Gebundene Ausgabe
Anzahl der Seiten
367
Kontakt zum Hersteller
CRC Press
https://www.routledge-ny.com

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