Pharmaceutical statistics : practical and clinical applications

著者

書誌事項

Pharmaceutical statistics : practical and clinical applications

Sanford Bolton, Charles Bon

(Drugs and the pharmaceutical sciences, v. 135)

Marcel Dekker, c2004

4th ed., revised and expanded

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注記

Includes bibliographical references and index

内容説明・目次

内容説明

The fourth edition of a bestselling text, this book covers the use of statistics in pharmaceutical research and clinical evaluation. It includes a disk with special prograns to aid in problem analysis. The coverage progresses from basic definitions and concepts, data graphics, and probability through ANOVA, factorial designs, and optimization techniques. The discussion and examples have been expanded to include GMPs, validation, and quality control, as well as procedures and analyses in bioequivalence studies. The text presents fresh material on concept conformity and release targets and describes linear regression and correlation, the analysis of variance, and crossover designs.

目次

  • Basic definitions and concepts
  • data graphics
  • introduction to probability - the binomial and normal probability distributions
  • choosing samples
  • statistical inference - estimation and hypothesis testing
  • sample size and power
  • linear regression andcorrelation
  • analysis of variance
  • factorial designs
  • transformations and outliers
  • experimental design in clinical trials
  • quality control
  • validation
  • computer-intensive methods
  • nonparametric methods
  • optimization techniques and screening designs.Appendices: some properties of the variance
  • comparison of slopes and testing of linearity - determination of relative potency
  • multiple regression
  • tables
  • outlier tests and chemical assays
  • should a single unexplained failing assay be reason to reject abatch
  • answers to exercises.

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