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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTechnology/Application

Human Factors Studies for Injectable Combination Products: From Planning to Reporting

John K. Towns
PDA Journal of Pharmaceutical Science and Technology July 2014, 68 (4) 347-361; DOI: https://doi.org/10.5731/pdajpst.2014.00983
John K. Towns
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 47906
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  • For correspondence: towns@lilly.com
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References

  1. 1.↵
    FDA. Design Control Guidance for Medical Device Manufacturers, March 11, 1997.
  2. 2.↵
    1. Weinger M. B.,
    2. Wiklund M. E.,
    3. Gardner-Bonneau D. J.
    Handbook of Human Factors in Medical Device Design; CRC Press: Boca Raton, FL, 2011.
  3. 3.↵
    ISO/IEC 62366:2007, Medical devices—Application of usability engineering to medical devices. Geneva, International Electrotechnical Commission.
  4. 4.↵
    AAMI/ANSI HE75:2009, Human Factors Engineering—Design of Medical Devices.
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    AAMI/ANSI/ISO 14971:2012, Medical Devices—Application of risk management to medical devices. International Organization for Standardization: Geneva, Switzerland.
  6. 6.↵
    ISO/IEC 60601-1-8:2006, Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. International Electrotechnical Commission: Geneva, Switzerland.
  7. 7.↵
    AAMI/ANSI HE74:2001/(R)2009, Human Factors Design Process for Medical Devices.
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    FDA Guidance for Industry and FDA Premarket and Design Control Reviewers Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. July 2000.
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    FDA Draft Guidance for Industry and FDA Staff, Applying Human Factors and Usability Engineering to Optimize Medical Device Design. June 2011.
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    FDA Draft Guidance for Industry and FDA Staff: Design Considerations for Devices Intended for Home Use. December 2012.
  11. 11.
    FDA Draft Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors. December 2012.
  12. 12.
    FDA Draft Guidance for Industry and FDA Staff: Submissions for Post-approval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA. January 2013.
  13. 13.↵
    FDA Draft Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors. April 2013.
  14. 14.
    FDA Draft Guidance for Industry and FDA Staff: Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization (ISO) Standard 11040-4. April 2013.
  15. 15.↵
    FDA Draft Guidance for Industry, Rheumatoid Arthritis: Developing Drug Products for Treatment. May 2013.
  16. 16.
    FDA Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products. June 2013.
  17. 17.↵
    1. Faulkner L.
    Beyond the five-user assumption: benefits of increased sample sizes in usability testing. Behavior Research Methods, Instruments, and Computers 2003, 35 (3), 379–383.
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    Master Files: Introduction to Master Files for Devices (MAFs), FDA CDRH Website, www.fda.gov/MedicalDevices/DeviceRegulationsandGuidance.
  19. 19.↵
    FDA Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers. April 2001.
  20. 20.↵
    Wyeth vs Levine, 555 U.S. 555, Supreme Court of United States, Decision: March 4, 2009.
  21. 21.↵
    FDA Guidance. Deciding When to Submit a 510(k) for a Change to an Existing Device, January 4, 1997.
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 68 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 4
July/August 2014
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Human Factors Studies for Injectable Combination Products: From Planning to Reporting
John K. Towns
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 347-361; DOI: 10.5731/pdajpst.2014.00983

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Human Factors Studies for Injectable Combination Products: From Planning to Reporting
John K. Towns
PDA Journal of Pharmaceutical Science and Technology Jul 2014, 68 (4) 347-361; DOI: 10.5731/pdajpst.2014.00983
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Jump to section

  • Article
    • Abstract
    • Introduction
    • Renewed Emphasis on HF
    • Scope of HF
    • Risk Evaluation and Mitigation
    • Formative Evaluations and Summative Validation HF Testing
    • Training Decay
    • Submitting HF Protocols
    • End User Groups
    • Usability Testing and Clinical Experience
    • Submission of HF in Marketing Application
    • Promotional Claims
    • Post-Approval Changes
    • Conclusions
    • Conflict of Interest Declaration
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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Keywords

  • Human factors
  • Devices
  • Regulatory
  • Combination products
  • Injectable
  • User groups
  • Submission

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