Tuesday, 24 May 2005 - 9:40 AM

This presentation is part of: Pharmacokinetics in Drug Discovery and Development

Human dose projection from pre clinical CNS models: Lundbeck experience

Gamini Chandrasena, Lundbeck US Research, Paramus, NJ

It is often the practice at Lundbeck Research, USA to perform human dose projections of their discovery leads, prior to recommendation for early development evaluation. We have been using number of approaches, including microsomal and hepatocyte Clint predictions as well as allometric scaling of modeled PK parameters to predict minimum human efficacy dose. In the case of SSRI inhibitors, the corresponding CNS target occupancy will be incorporated, as well, to strengthen the dose predictions. The pre-clinical utilization of these approaches for early human dose projections will be discussed.

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