By Scott D. Patterson,Byron Jones

ISBN-10: 1584885300

ISBN-13: 9781584885306

conserving a realistic viewpoint, Bioequivalence and statistics in scientific Pharmacology explores records utilized in daily medical pharmacology paintings. The publication covers the tools had to layout, examine, and interpret bioequivalence trials; explores whilst, how, and why those stories are played as a part of drug improvement; and demonstrates the proposed equipment utilizing genuine global examples.

Drawing on wisdom won without delay from operating within the pharmaceutical undefined, the authors set the level by way of describing the final position of records. as soon as the basis of scientific pharmacology drug improvement, regulatory functions, and the layout and research of bioequivalence trials are verified, they movement directly to comparable subject matters in medical pharmacology related to using cross-over designs. those comprise, yet aren't constrained to, safeguard reports in part I, dose-response trials, drug interplay trials, food-effect and mix trials, QTc and different pharmacodynamic equivalence trials, and dose-proportionality trials. Purposefully designed to be immediately appropriate, the publication offers examples of SAS code in order that the research defined could be instantly carried out. The authors have made broad use of the proc combined approaches to be had in SAS.

Each bankruptcy incorporates a vignette in keeping with co-author Scott Patterson's adventure within the scientific pharmacology paintings position and the entire info units are taken from actual trials. The authors delineate sensible application and goals, supply real-world examples of the subject less than dialogue, and comprise statistical concept and functions. Technical conception, the place wide, is incorporated in technical appendices on the finish of the bankruptcy. each one subject comprises labored examples that illustrate the purposes of the statistical strategies and their interpretation. The authors additionally boost statistical instruments helpful for different issues of scientific pharmacology - specifically common safeguard trying out, trying out for proarrythmic strength, inhabitants pharmacokinetics, and dose-selection.

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Bioequivalence and Statistics in Clinical Pharmacology (Chapman & Hall/CRC Biostatistics Series) by Scott D. Patterson,Byron Jones


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