Parent Drug and Active Metabolite (FDA) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2006-05-10 10:22 (6647 d 01:43 ago) – Posting: # 123
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❝ […] would this mean that ANOVA on the metabolite data is not necessary?


Hi Joy,

yes, IMHO no confidence interval of the metabolite; you should present just means, standard deviations, etc. If you opt to present a confidence interval make clear in the protocol, that there's no acceptance range for it.

The wonderful thing about FDA is that you have to present the study protocol to them anyhow; if they don't like it, they will tell you ;-)

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