Maximum Tolerated Dose Evaluation of the AMPA Modulator Org 26576 in Healthy Volunteers and Depressed Patients: A Summary and Method Analysis of Bridging Research in Support of Phase II Dose Selection

BACKGROUND: A key challenge to dose selection in early central nervous system (CNS) clinical drug development is that patient tolerability profiles often differ from those of healthy volunteers (HVs), yet HVs are the modal population for determining doses to be investigated in phase II trials. Witho...

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Detalles Bibliográficos
Autores principales: Nations, Kari R., Bursi, Roberta, Dogterom, Peter, Ereshefsky, Larry, Gertsik, Lev, Mant, Tim, Schipper, Jacques
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2012
Materias:
Original Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3585695/
https://www.ncbi.nlm.nih.gov/pubmed/22852579
http://dx.doi.org/10.2165/11634360-000000000-00000

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