Impact of the U.S. Food and Drug Administration cardiovascular assessment requirements on the development of novel antidiabetes drugs - PubMed (original) (raw)

Impact of the U.S. Food and Drug Administration cardiovascular assessment requirements on the development of novel antidiabetes drugs

Boaz Hirshberg et al. Diabetes Care. 2011 May.

No abstract available

Figures

Figure 1

FDA CV safety: CI bars. The FDA guidelines provide statistical hurdles for approval. Five hypothetical examples of possible hazard ratios and the upper limit of the 95% CI of a development plan are shown as well as the regulatory consequences of each outcome.

Figure 2

Total CV events needed to fall below the FDA target cutoff of 1.8. Assuming a novel antidiabetes drug is neutral in terms of CV disease, a program should accrue ~120 CV events to provide adequate power to meet the FDA requirement.

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Impact of the U.S. Food and Drug Administration cardiovascular assessment requirements on the development of novel antidiabetes drugs - PubMed (original) (raw)