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FIH EMEA Trial Guidelines

CONDUCTING A FIRST-IN-HUMAN TRIAL IN THE LIGHT OF THE 2007 EMEA GUIDELINE

Over last two years, several European regulatory bodies revisited the recommendations on the content of the pre-clinical studies that support the First-In-Human (FIH) clinical application and the estimation of the starting dose and dose progression. Overall, these changes have a noticeable impact on the way the FIH trials are now conducted.

Complete the form below to learn more about how FIH Trials are being implemented.

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