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Item Details
Title: BIOEQUIVALENCE AND STATISTICS IN CLINICAL PHARMACOLOGY, SECOND EDITION
By: Scott D. Patterson, Byron Jones
Format: Electronic book text

List price: £76.99


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ISBN 10: 1466585218
ISBN 13: 9781466585218
Publisher: TAYLOR & FRANCIS INC
Pub. date: 29 December, 2016
Edition: 2nd New edition
Series: Chapman & Hall/CRC Biostatistics Series
Pages: 434
Synopsis: Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition explores statistics used in day-to-day clinical pharmacology work. The book is a starting point for those involved in such research and covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrates the methods using real world examples. Drawing on knowledge gained directly from working in the pharmaceutical industry, the authors set the stage by describing the general role of statistics. Once the foundation of clinical pharmacology drug development, regulatory applications, and the design and analysis of bioequivalence trials are established,? including recent regulatory changes in design and analysis and in particular sample-size adaptation, they move on to related topics in clinical pharmacology involving the use of cross-over designs. These include, but are not limited to, safety studies in Phase I, dose-response trials, drug interaction trials, food-effect and combination trials, QTc and other pharmacodynamic equivalence trials, proof-of-concept trials, dose-proportionality trials, and vaccines trials.? This second edition addresses several recent developments in the field, including new chapters on adaptive bioequivalence studies, scaled average bioequivalence testing, and vaccine trials.Purposefully designed to be instantly applicable, Bioequivalence and Statistics in Clinical Pharmacology, Second Edition provides examples of SAS and R code so that the analyses described can be immediately implemented. The authors have made extensive use of the proc mixed procedures available in SAS.
Illustrations: 75 Illustrations, black and white
Publication: US
Imprint: Chapman & Hall/CRC
Returns: Non-returnable
Some other items by this author:
BEGINNINGS
BIOEQUIVALENCE AND STATISTICS IN CLINICAL PHARMACOLOGY
BIOEQUIVALENCE AND STATISTICS IN CLINICAL PHARMACOLOGY
BIOEQUIVALENCE AND STATISTICS IN CLINICAL PHARMACOLOGY (HB)
BIOEQUIVALENCE AND STATISTICS IN CLINICAL PHARMACOLOGY (HB)
DATA AND SAFETY MONITORING COMMITTEES IN CLINICAL TRIALS (HB)
DESIGN AND ANALYSIS OF CLINICAL TRIALS WITH TIME-TO-EVENT ENDPOINTS (HB)
DESIGN AND ANALYSIS OF CROSS-OVER TRIALS
DESIGN AND ANALYSIS OF CROSS-OVER TRIALS
DESIGN AND ANALYSIS OF CROSS-OVER TRIALS (HB)
DESIGN AND ANALYSIS OF CROSS-OVER TRIALS (HB)
DESIGN AND ANALYSIS OF CROSS-OVER TRIALS, SECOND EDITION
DESIGN AND ANALYSIS OF CROSS-OVER TRIALS, THIRD EDITION
DESIGN AND ANALYSIS OF MULTICENTRE CLINICAL TRIALS (HB)
FRAILTY MODELS IN SURVIVAL ANALYSIS (HB)
INFLATION IN ENGINEERING ECONOMIC ANALYSIS (HB)
STATISTICAL INFERENCE (HB)
STATISTICS: PROBLEMS AND SOLUTION (HB)
STATISTICS: PROBLEMS AND SOLUTION (PB)



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