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Asbjørn Nøhr-Nielsen

Asbjørn Nøhr-Nielsen

PhD fellow

The focus of the Ph.D. project is to assess the body of evidence submitted with a Marketing Authorization Applications (MAAs) to obtain approval for authorization of FDCs in the EU, with a specific focus on the number and size of clinical trials, characteristics of FDC, dose selection process including dose ratio, in order to propose strategies to improve the development process of FDC products. Additionally, the project will explore if modelling and simulation could have facilitated the entire developmental process thereby saving time and resources or alternatively if the modelling and simulation could have increased the power of some of the studies.

ID: 170489549