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Development of innovative drugs has recently become more difficult. The case of rosiglitazone shows the extreme difficulty of making the regulatory decision that will best balance the benefits and risks of a drug. There is a high expectation that regulatory science (RS) can improve the situation. However, without user understanding of its basic characteristics, RS will not deliver what is expected. Clinical Pharmacology & Therapeutics (2011) 90 1, 29–31. doi:10.1038/clpt.2011.89
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Tominaga et al. (2011) studied this question.
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