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A survey of current practices in the US regarding minorities and gender: the pharmaceutical perspective

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The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines

Part of the book series: CMR Workshop Series ((CMRW))

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References

  • Boston Consulting Group (BCG) Report (1993). The Changing Environment for US Pharmaceuticals. The Role of the Pharmaceutical Companies in a Systems Approach to Healthcare. Sponsored by Pfizer Inc. Available on request (USA).

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  • Di Masi J, Hansen R, Grabowski H and Lasagna L (1991). The cost of innovation in the pharmaceutical industry new drug R&D cost estimates. J Hlth Econon, 10:107–142.

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  • Food and Drug Administration (FDA) Department of Health and Human Services Public Health Service (1988). Guideline for the format and content of the clinical and statistical sections of new drug applications. Federal Register, Volume, 53, October 1988.

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  • Food and Drug Administration (FDA) (1993). Guideline for the study and evaluation of gender differences in the clinical evaluation of drugs. Federal Register, Volume 58, July 1993.

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  • General Accounting Office (GAO) (1992). Women’s health: FDA need to ensure more study of gender differences in prescription drug testing. GAO, October 1992, Washington DC.

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  • Schroeder P, Snowe O and Mikuisici B (1993). Pharmaceutical Testing Fairness Act (HR 2695) Section M Congressional Proposed Bill. Women’s Equity Act of 1993.

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Authors
  1. Lionel D. Edwards
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Editor information

Editors and Affiliations

  1. Centre for Medicines Research, Carshalton, Surrey, UK

    Stuart Walker (Director), Cyndy Lumley (Associate Director) & Neil McAuslane (Project Manager) (Director),  (Associate Director) &  (Project Manager)

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© 1994 Springer Science+Business Media Dordrecht

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Edwards, L.D. (1994). A survey of current practices in the US regarding minorities and gender: the pharmaceutical perspective. In: Walker, S., Lumley, C., McAuslane, N. (eds) The Relevance of Ethnic Factors in the Clinical Evaluation of Medicines. CMR Workshop Series. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-1420-2_8

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  • DOI: https://doi.org/10.1007/978-94-011-1420-2_8

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-94-010-4621-3

  • Online ISBN: 978-94-011-1420-2

  • eBook Packages: Springer Book Archive

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