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The pharma company view

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  • 27 March 2018

    This article was initially published with an incorrect DOI. A new DOI has been assigned and registered at Crossref, and has been corrected in the article.

References

  1. Powers, J.H. Clin. Microbiol. Infect. 10 (Suppl 4), 23–31 (2004).

    Article  Google Scholar 

  2. Weber, J.T. & Courvalin, P. Emerg. Infect. Dis. 11, 791–792 (June 2005).

    Article  CAS  Google Scholar 

  3. Commission of the European Communities. Communication from the Commission on a Community Strategy Against Antimicrobial Resistance (European Commission, Brussels, Belgium, 2001).

  4. World Health Organization. WHO Global Strategy for the Containment of Antimicrobial Resistance (WHO, Geneva, 2001).

  5. Nordberg, P., Monnet, D.L. & Cars, O. Antibacterial Resistance. Background Document for the WHO Project: Priority Medicines for Europe and the World—a Public Health Approach to Innovation (WHO, Geneva, 2005). <http://mednet3.who.int/prioritymeds/report/index.htm>

    Google Scholar 

  6. Norrby, S.R., Nord, C.E. & Finch, R. Lancet Infect. Dis. 5, 115–119 (2005).

    Article  Google Scholar 

  7. Smolinski, M.S., Hamburg, M.A. & Lederberg, J. (eds.). Microbial Threats to Health: Emergence, Detection, and Response (Institute of Medicine, Washington, DC, 2003).

    Google Scholar 

  8. Task Force on Antimicrobial Availability. Bad Bugs, No Drugs: As Antibiotic R&D Stagnates, a Public Health Crisis Brews (Infectious Diseases Society of America, Alexandria, Virginia, July 2004). <http://www.idsociety.org/pa/IDSA_Paper4_final_web.pdf>

  9. Talbot, G.H. et al. Clin. Infect. Dis. 42, 657–668 (2006).

    Article  Google Scholar 

  10. Spellberg, B., Powers, J.H., Brass, E.P., Miller, L.G. & Edwards, J.E., Jr. Clin. Infect. Dis. 38, 1279–1286 (2004).

    Article  CAS  Google Scholar 

  11. Livermore, D.M. Clin. Microbiol. Infect. 10 (Suppl 4), 1–9 (2004).

    Article  Google Scholar 

  12. US Food and Drug Administration. Guidance for Industry: Developing Antimicrobial Drugs—General Considerations for Clinical Trials (FDA, Rockville, Maryland, July 1998). <http://www.fda.gov/Cder/guidance/2580dft.pdf>

  13. European Medicines Agency/Committee for Proprietary Medicinal Products. Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections (EMEA/CPMP, London, October 2004). <http://www.emea.eu.int/pdfs/human/ewp/055895en.pdf>

  14. Japan Pharmaceutical and Medicine Safety Bureau, Evaluation and Licensing Division. Guidelines for the Clinical Evaluation of Antibacterial Drugs (PMSB/ELD, Tokyo, August 1998).

  15. US Food and Drug Administration. Guidelines for the Clinical Evaluation of Anti-Infective Drugs (Systemic Adults and Children) (FDA, Rockville, Maryland, September 1977). <http://www.fda.gov/Cder/guidance/old047fn.pdf>

  16. US Food and Drug Administration. FDA Points to Consider—Clinical Development and Labeling of Anti-Infective Drug Products. (FDA, Rockville, Maryland, October 1992). <http://www.fda.gov/cder/guidance/ptc.htm>

  17. Blaser, M.J. & Bartlett, J.G. Letter to Acting Commissioner of Food and Drugs Administration. (September 28, 2006). <http://www.idsociety.org/Template.cfm?Section=Home&Template=/ContentManagement/ContentDisplay.cfm&ContentID=17039>

  18. Getz, K.A. A swift predominance of ex-US sites. Applied Clinical Trials Magazine, December 1, 2005. <http://www.actmagazine.com/appliedclinicaltrials/article/articleDetail.jsp?id=261633>

    Google Scholar 

  19. Bakhle, D. Global Clinical Trials in India—Challenges and Opportunities. Business Briefing Pharmatech (Touch Briefings, London, 2003). <http://www.touchbriefings.com/pdf/17/pt031_r_4_bakhle.pdf>

    Google Scholar 

  20. International Conference on Harmonization. ICH Harmonized Tripartite Guideline. E5: Ethnic Factors in the Acceptability of Foreign Clinical Data. (ICH, Geneva, February 1998). <http://www.ich.org/cache/compo/475-272-1.html#E5>

  21. Temple, R. & Ellenberg, S.S. Ann. Intern. Med. 133, 455–463 (2000).

    Article  CAS  Google Scholar 

  22. International Conference on Harmonization. ICH Harmonized Tripartite Guideline. E9: Statistical Principles for Clinical Trials (ICH, Geneva, February 1998). <http://www.ich.org/cache/compo/475-272-1.html#E9>

  23. International Conference on Harmonization. ICH Harmonized Tripartite Guideline. E10: Choice of Control Group and Related Issues in Clinical Trials. (ICH, Geneva, July 2000). <http://www.ich.org/cache/compo/475-272-1.html#E10

  24. US Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for Industry. E9 Statistical Principles for Clinical Trials (FDA, Rockville, Maryland, 1998). <http://www.fda.gov/cder/guidance/ICH_E9-fnl.pdf>

  25. Federal Food, Drug, and Cosmetic Act, Chapter V—Drugs and Devices Subchapter A, Drugs and Devices, Section 505. <http://www.fda.gov/opacom/laws/fdact/fdtoc.htm>

  26. US Food and Drug Administration. Guidance for Industry. Population Pharmacokinetics (FDA, Rockville, Maryland, February 1999). <http://www.fda.gov/cder/guidance/1852fnl.pdf>

  27. US Food and Drug Administration. Antimicrobial Resistance & Drug Development: FDA/IDSA/ISAP Working Group Presentations and Transcripts (FDA, Rockville, Maryland, May, 2004). <http://www.fda.gov/cder/drug/antimicrobial/FDA_IDSA_ISAP_Presentations.htm>

  28. Bradley, J.S., Dudley, M.N. & Drusano, G.L. Pediatr. Infect. Dis. J. 22, 982–992 (2003).

    Article  Google Scholar 

  29. Metlay, J.P., Powers, J.H., Dudley, M.N., Christiansen, K. & Finch, R.G. Emerg. Infect. Dis. 12, 183–190 (2006).

    Article  Google Scholar 

  30. US Food and Drug Administration. General Principles EMEA-FDA Parallel Scientific Advice Meetings Pilot Program (FDA, Rockville, Maryland, May, 2004). <http://www.fda.gov/oia/pilotprogram0904.html>

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Brenner, R., Ellis-Grosse, E. The pharma company view. Nat Biotechnol 24, 1515–1519 (2006). https://doi.org/10.1038/nbt1206-1515b

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