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Expert Review of Pharmacoeconomics & Outcomes Research Volume 12, 2012 - Issue 3
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Editorial

Value for money of drug regulation

Jacoline C Bouvy Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands and Faculty of Health Policy and Management, Institute for Medical Technology Assessment (iMTA), Erasmus University Rotterdam, Rotterdam, The Netherlands. [email protected]
,
Marc A Koopmanschap Faculty of Health Policy and Management, Institute for Medical Technology Assessment (iMTA), Erasmus University Rotterdam, Rotterdam, The Netherlands
&
Huub Schellekens Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, The Netherlands and Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands
Pages 247-249 | Published online: 09 Jan 2014

References

  • Ratanawijitrasin S, Wondemagegnehu E. Effective Drug Regulation: A Multicountry Study. WHO, Geneva, Switzerland (2002).
  • Munos B. Lessons from 60 years of pharmaceutical innovation. Nat. Rev. Drug Discov. 8(12), 959–968 (2009).
  • Scannell JW, Blanckley A, Boldon H, Warrington B. Diagnosing the decline in pharmaceutical R&D efficiency. Nat. Rev. Drug Discov. 11(3), 191–200 (2012).
  • Greener M. First do no harm. Improving drug safety through legislation and independent research. EMBO Rep. 9(3), 221–224 (2008).
  • Nada A, Somberg J. First-in-Man (FIM) clinical trials post-TeGenero: a review of the impact of the TeGenero trial on the design, conduct, and ethics of FIM trials. Am. J. Ther. 14(6), 594–604 (2007).
  • Shah RR. Can pharmacogenetics help rescue drugs withdrawn from the market? Pharmacogenomics 7(6), 889–908 (2006).
  • Bouvy JC, Koopmanschap MA, Shah RR, Schellekens H. The cost–effectiveness of drug regulation: the example of thorough QT/QTc studies. Clin. Pharmacol. Ther. 91(2), 281–288 (2012).
  • Bouvy J, Weemers J, Schellekens H, Koopmanschap M. Willingness to pay for adverse drug event regulatory actions. Pharmacoeconomics 29(11), 963–975 (2011).

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