ISCTM Second Annual Meeting 2006
Day 1 (21 February 2006)
| Welcome and state of ISCTM | A.G. Awad President, ISCTM |
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| Current concepts of long-term efficacy in psychiatric disorders: problems and opportunities | R. Baldessarini | |
| Session I: Treatment Resistance: New designs and regulatory opportunities | Co-chairs: G. Awad, M. Rapaport |
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| Treatment Resistance in psychiatry Study methodology and design issues Statistical issues US Regulatory perspective EU Regulatory perspective |
J. Davis R. Anand W. Olson R. Levin C. Sampaio |
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| Summary and discussion | M. Rapaport | |
Day 2 (22 February 2006)
| Session II: Drug Development for Parkinson's Disease: Beyond Motor Control | Co-chairs: J. Friedman, R. Anand |
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| Treatment of motor symptoms of PD - state of the art and unresolved issues Behavioral disturbances in PD Cognition in PD Regulatory perspective of treatment of non motor syndromes in PD |
W. Olanow J. Friedman J. Kulisevsky C. Sampaio |
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Summary and discussion |
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| Session III: "Defining dose for psychopharmacological agents in early development" | S. Potkin L. Alphs |
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| Objectives, issues and evolving strategies Prediction of dose for Phase I in humans: - Extrapolation of pharmacological data - Extrapolation of toxicological results Defining dose for Phase 2 efficacy and safety studies: - Pharmacokinetics, tolerability and experimental data |
S. Potkin W. Potter L. Ereshefsky |
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| Summary and discussion | L. Alphs | |
| Thorny issues in CNS methodology | A. Mahableshwarkar | |
| Session IV: "Defining dose for psychopharmacological agents - Phase III and beyond" | Co-Chairs: L. Ereshefsky W. Olson |
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| Analyses to define therapeutic dose range Post marketing assessment of dose response Statistical issues EU regulatory assessment of dose response US regulatory assessment of dose response |
R. Anand R. Mahmoud J. Weaver C. Sampaio |
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| Discussion | ||