Statistics in Drug Research

Methodologies and Recent Developments

Shein-Chung Chow, Jun Shao (Autoren)

Buch | Softcover

388 Seiten

2019
CRC Press (Verlag)
978-0-367-39633-6 (ISBN)

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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.

Chow, Shein-Chung; Shao, Jun

Introduction. harmaceutical Validation. Dissolution Testing. Stability Analysis. Bioavailability and Bioequivalence. Randomization and Blinding. Substantial Evidence In Clinical Development. Therapeutic Equivalence and Noninferiority. Analysis of Incomplete Data. Meta-Analysis. Quality of Life. Medical Imaging. References. Index.

Erscheinungsdatum	30.09.2019
Verlagsort	London
Sprache	englisch
Maße	156 x 234 mm
Gewicht	453 g
Themenwelt	Mathematik / Informatik ► Mathematik ► Statistik
	Medizin / Pharmazie
	Naturwissenschaften ► Biologie
	Technik
ISBN-10	0-367-39633-5 / 0367396335
ISBN-13	978-0-367-39633-6 / 9780367396336
Zustand	Neuware