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Original Articles

Assessing Dose–Region Profile of Drug Efficacy: A Multiregional Trial Strategy

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Pages 894-902 | Received 15 Oct 2010, Accepted 04 May 2012, Published online: 04 Sep 2012

REFERENCES

  • Chen , Y. H. , Wu , Y. H. , Wang , M. ( 2009 ). A Bayesian approach to evaluating regional treatment effect in a multiregional trial . Journal of Biopharmaceutical Statistics 19 : 900 – 915 .
  • International Conference on Harmonization. (1998). Tripartite guideline E9 on statistical principals for clinical trials. Available at: http://www.emea.europa.eu/pdfs/human/ ich/036396en.pdf
  • Malinowski , H. J. , Westelinck , A. , Sato , J. , Ong , T. ( 2008 ). Same drug, different dosing: Differences in dosing for drugs approved in the United States, Europe, and Japan . Journal of Clinical Pharmacology 48 : 900 – 908 .

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