Whitepaper: How the revised EMA guidance on First in Human clinical trials affects your study design

Our understanding of disease using data, technology and innovation has led to exponential developments in translational science and in all phases of clinical development. The new EMA guidelines on FIH studies open and guide the integration of non-clinical data in PK, PD and toxicology with modern, adaptive design and modelling and simulation tools. This facilitates greater safety, precision and efficiency in early phase study designs. Click below to download your free Whitepaper.

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