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FDAnews Drug Daily Bulletin

EMA to Update Aging ICH Guidelines on Trial Statistics and Reproductive Toxicology

Sept. 6, 2017

The European Medicines Agency has begun to adopt a new addendum to the ICH’s 1998 clinical trial statistics guideline, as well as a revision to the 23-year-old ICH guideline on measuring drug risks to human reproduction.

The E9 addendum on clinical trial statistics was designed to assist in preparing data summaries or assessing evidence from clinical trials in later phases of development, and it clarifies and extends the original guideline.

The addendum focuses mainly on sensitivity analyses and targets for estimation and measurement.

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