Dose Finding in Drug Development
Adequate dose finding is essential in clinical drug development for achieving regulatory approval. Uncertainty pertaining to the adequacy of the proposed marketing dose(s) is a frequent reason for denial of new molecular entity (NME) applications and a significant number of marketing authorization applications has major objections raised due to unjustified doses.
At this PopSim meeting we will have a close look at what data is usually included in a regulatory submission to justify the proposed dose(s) and learn about a new paradigm for dose finding where the focus is not on finding ‘the optimal dose’. Finally, we will hear about a model-based simulation study investigating how knowledge of patient-specific dose response information can be utilised.
|14:35||Dose finding in the clinical development of 60 FDA-approved drugs||Yassine Kamal Lyauk|
|15:05||A New Paradigm. ‘Learn – Learn More’; Dose-Exposure-Response at the Center of Drug Development and Regulatory Approval||Alan Maloney|
|15:45||Coffee break and networking|
|16:30||Utilisation of patient-specific dose response information for optimising treatment outcome||Christian Møller Hansen|
|16:55||Closing remarks||Daniël Jonker|
We are happy that COVID-19 is currently (as of June) not in the way for having this meeting. If the situation changes we may need to adjust and you will be informed about any changes. As Ferring currently has restrictions on how many people can enter the elevators, please make sure to arrive in good time before the meeting starts. Also, feel free to forward this invitation to any colleagues with an interest in dose finding, for example your colleagues with a regulatory background who may find this meeting to be highly relevant.