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. Cove
Auflage
Sprache
Verlagsort
Verlagsgruppe
Zielgruppe
Für Beruf und Forschung
Biostatisticians; pharmacologists; clinical, industrial, and research pharmacists; statisticians and applied statisticians; biometricians; quality control personnel; drug regulatory personnel; and upper-level undergraduate and graduate students in these disciplines
Dateigröße
ISBN-13
978-0-203-91014-6 (9780203910146)
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Schweitzer Klassifikation
Introduction Pharmaceutical 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