Intas Pharmaceut Ltd Biopharma;
Cambridge Consultants;
Lobal Med Technol Div;
Res & Dev;
关键词：
dose accuracy;
human factors;
safety and effectiveness;
formative and validation;
Teriparatide pen;
期刊名称：
Expert opinion on biological therapy
i s s n：
1471-2598
年卷期：
2022 年
22 卷
1/6 期
页 码：
331-343
页 码：
摘 要：
Background A thorough Human Factors Engineering (HFE) process was implemented to develop a new Teriparatide Pen for the treatment of osteoporosis. The pen provides a cost-effective treatment alternative to branded teriparatide pens. The HFE process ensured that the pen was safe and effective to use and fulfilled the regulatory requirements. Research Design and Methods The HFE process utilized a risk-based approach that included understanding the users and other use characteristics, preliminary analyses including a thorough risk assessment, a formative and two validation studies. The studies were carried out with intended users - patients, caregivers and healthcare professionals (HCPs) - in the form of simulated use assessments. Results The preliminary analyses supported the design of the pen's user interface, including its Instructions for Use (IFU). The formative study helped to optimize the user interface. The validation study results were largely favorable but indicated a minor scope for improvement. The IFU was therefore further improved, and a bridging validation study assessed the revised IFU and found it to be effective in supporting the correct use of the pen. Conclusions The HFE process ensured and demonstrated that the Teriparatide Pen was safe and effective for its intended use.
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