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Statistical Review

The New Drug Development Process.

Statisticians evaluate the statistical relevance of the data in the NDA with the main tasks of evaluating the methods used to conduct studies and the various methods used to analyze the data. The purpose of these evaluations is to give the medical officers a better idea of the power of the findings to be extrapolated to the larger patient population in the country.




Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.


Back to The New Drug Development Process

 
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