25/03/2021 - Elham

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The calculation of adequate sample size is crucial in any safety pharmacology study. Power calculation it is the process by which we calculate the optimum number of animals required to arrive at ethically and scientifically valid results. Power calculations uses mathematics/statistical equations, which describe  the relationship between the expected effect size of biological interest, standard deviation (SD) of the data, significance level (usually p <0.05 ), desired power, sample size, and the alternative H0 (null hypothesis). A study with too small sample size may produce inconclusive and unreliable results. 

As part of my PhD project, I will develop data analysis workflows that enable efficient exploration of values of control groups reported in historical safety studies. Moreover, we believe that a better understanding of factors inducing variation in historical studies may help to improve future study designs.

References:

  1. Fitzpatrick, R. (n.d.). Why is sample Size important? Retrieved February 03, 2021, from https://blog.statsols.com/why-is-sample-size-important/ 
  2. Kadam, P., & Bhalerao, S. (2010, January). Sample size calculation. Retrieved February 03, 2021, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2876926/