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Statistics in Pharmaceutical Safety Assessment

A major difficulty is that there is a very real necessity to understand the biological realities and implications of a problem, as well as to understand the peculiarities of toxicological data before procedures are selected and employed for analysis. These characteristics include the following. [Pg.862]

The need to work with a relatively small sample set of data collected from the members of a population (laboratory animals) that is not actually our population of interest (that is, humans or a target animal population). [Pg.863]

The time frames available to solve our problems are limited by practical and economic factors. This frequently means that there is no time to repeat a critical study if the first attempt fails. So a true iterative approach is not possible. [Pg.863]

The training of most pathologists in statistics remains limited to a single introductory course which concentrates on some theoretical basics. As a result, the armertarium of statistical techniques of most toxicologists is limited and the tools that are usually present (t-tests, chi-square, analysis of variance, and linear regression) are neither fully developed nor well understood. It is hoped that this chapter will help change this situation. [Pg.863]

As a point of departure toward this objective, it is essential that any analysis of study results be interpreted by a professional who firmly understands three concepts the difference between biological significance and statistical significance, the nature and value of different types of data, and causality. [Pg.863]

STATISTICS IN PHARMACEUTICAL SAFETY ASSESSMENT where S (variance) can be calculated from... [Pg.922]

See other pages where Statistics in Pharmaceutical Safety Assessment is mentioned: [Pg.862]    [Pg.864]    [Pg.866]    [Pg.868]    [Pg.870]    [Pg.872]    [Pg.874]    [Pg.876]    [Pg.878]    [Pg.880]    [Pg.882]    [Pg.884]    [Pg.888]    [Pg.890]    [Pg.892]    [Pg.896]    [Pg.898]    [Pg.900]    [Pg.902]    [Pg.904]    [Pg.906]    [Pg.908]    [Pg.910]    [Pg.912]    [Pg.914]    [Pg.916]    [Pg.918]    [Pg.920]    [Pg.924]    [Pg.926]    [Pg.928]    [Pg.930]    [Pg.932]    [Pg.934]    [Pg.936]    [Pg.938]    [Pg.940]    [Pg.942]    [Pg.944]    [Pg.946]    [Pg.948]    [Pg.950]    [Pg.952]    [Pg.954]    [Pg.956]    [Pg.958]    [Pg.960]    [Pg.962]    [Pg.964]    [Pg.966]   


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