| Other Laboratory Operations Food and Drug Administration |
| DOCUMENT NO.: III-04 | VERSION NO.:1.2 | Section 4 - Basic Statistics and Presentation | EFFECTIVE DATE: 10/01/2003 | REVISED: 06/27/2008 |
4.9 Statistics Applied to Biological Assays
Biological assays are those carried out by dosing a biological test system
(such as a rat or mouse) with the substance to be determined, and measuring
a response. An example is the USP monograph for Menotropins. This biological
extract contains Luteinizing Hormone (LH) and Follicle Stimulating Hormone
(FSH), which have effects on the reproductive organs. The assay consists of
dosing male (LH) and female (FSH) rats with menotropins and observing the effects
(weight) on the seminal vesicles and ovaries respectively after a multiple
day incubation time.
Although this type of assay will rarely be encountered in the ORA laboratory,
biological assays are instructive in the statistical complexity encountered
when dealing with highly variable systems such as live animals. The interpretation
of results is complicated by the fact that the total variance of a measurement
includes a large variance due to the biological component. The analyst may
also encounter these assays when on team inspections.
The subject of biological assays is addressed in General Chapter <111> of
the USP, "Design and Analysis of Biological Assays," where an
extensive statistical treatment is developed, based on the Analysis of Variance
(ANOVA). This is also one of the rare instances in the USP where rejection
of "outlier
data" is allowed, under strict statistical justification. The interested
reader is referred to <111> for further information.
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