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September 2020

Dose Finding in Drug Development

7. September @ 14:30 - 17:00
Ferring Pharmaceutical A/S, Kay Fiskers Plads 11
Copenhagen, Denmark
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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…

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