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Statistical Considerations for Implementing the FDA CV Guidance for T2DM

Statistical Considerations for Implementing the FDA CV Guidance for T2DM. Craig Wilson, PhD NIC-ASA Fall Meeting October 15, 2009. Regulatory History (1). Rosiglitazone (Avandia; GSK) TZD for treatment of T2DM Nissen and Wolski (May 2007) Meta-analysis of 42 studies (Ph2/3/4)

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Large safety trial - PowerPoint PPT Presentation

Statistical Considerations for Implementing the FDA CV Guidance for T2DM