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EMA backs model from Novartis to identify safest, most effective Phase III dose
Monday, February 24, 2014
AG has developed a new dosing model for Phase II trials that eliminates
much of the guesswork around dose selection for Phase III. EMA has endorsed the
model and the pharma is in discussions with FDA. And while it has its
limitations, European regulators are hopeful that the model could increase the
success of Phase III studies and reduce unwanted side effects.
One of the weaknesses of
traditional dose-finding in Phase II is that the actual shape of the
dose-response curve is usually unknown. As a result, companies are often just
making a best guess about the one or two doses to take into Phase III.
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