Bolton Sanford, Bon Charles. Pharmaceutical Statistics: Practical and Clinical Applications

5th ed., revised and expanded. — Informa Healthcare USA, Inc., 2010. — 674 p. —ISBN13: 978-1-4200-7422-2.Предлагая примеры и решения практического характера, книга является наиболее полным и детальным руководством по различным приложениям статистики к исследованиям в области фармацевтической индустрии, включая клинические эксперименты и оценку биоэквивалентности.Through the use of practical examples and solutions, Pharmaceutical Statistics: Practical and Clinical Applications, Fifth Edition provides the most complete and comprehensive guide to the various statistical applications and research issues in the pharmaceutical industry, particularly in clinical trials and bioequivalence studies.* Includes step-by-step examples for analyzing text examples using common software programs
* Covers the in vitro-in vivo correlation, and how it can be used in the drug development process to improve FDA acceptance of post-approval manufacturing changes
* Discusses adaptive designs in clinical research and advanced statistical designs in clinical trials with safety/efficacy endpoints
* Explains one- and two-sided statistical tests
* Covers interim and sequential analysis for clinical trials and bioequivalence studies
* Discusses assumptions and applications of nonparametric methods
* Includes the application of confidence intervals for a ratio based on Fieller’s Theorem
* Expands on the concepts of multiple and logistic regression
* Provides tables in the appendix to clarify material