Dosing certainty

Novartis 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...