Draft Qualification Opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of Phase II dose finding studies under model uncertainty
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Qualification Opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of Phase II dose finding studies under model uncertainty
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Qualification Opinion of MCP-Mod as an efficient statistical methodology for model-based design and analysis of Phase II dose finding studies under model uncertainty
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The statistical methodology for the design and analysis of clinical Phase II dose-response studies, with related software implementation, is well developed for the case of a normally distributed, homoscedastic response considered for a single timepoint in parallel group study designs. In practice, however, binary, count, or time-to-event endpoints are encountered, typically measured repeatedly ...
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