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Expert Opin Drug Deliv. 2019 Dec;16(12):1333-1353. doi: 10.1080/17425247.2019.1682995. Epub 2019 Oct 29.

Insights into human factor studies conducted for US FDA-approved biological combination products.

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Clinical Development & Medical Affairs, Intas Pharmaceuticals Limited (Biopharma), Ahmedabad, India.


Introduction: With increasing use of biological products and devices, importance of human factor (HF) studies is increasing. The HF study ensures safe and effective use of the device by intended users, for intended uses, under intended use environments.Areas covered: This review compiles information of HF studies conducted for biological combination products (biological products plus device) approved by US FDA's Center for Drug Evaluation and Research between 21 June 2011 and 31 December 2018. Information regarding product, indication, device type, administration frequency, and various aspects related to HF studies was collected from published documents.Expert opinion: Learnings from HF studies and known use-related problems of similar devices should be incorporated in the design of the device and the HF validation study. User profile, group, subgroup, and sample size are important aspects of the HF validation study. Early engagement with US FDA can be helpful to integrate the HF program with the overall device development program. It may not be possible to eliminate all use errors or risks for the device. Any residual risk after an HF validation study should be evaluated, and benefits of the device use should outweigh the residual risk.Abbreviations: BCP: biological combination product; BLA: Biological License Application; CDER: Center of Drug Evaluation and Research; FDA: Food and Drug Administration; FDC: Food Drug and Cosmetic; HCP: healthcare professional; HF: human factor; IFU: instructions for use; NDA: New Drug Application; PFS: pre-filled syringe; PHS: Public Health Service; PI: prescribing information; US: United States.


Autoinjector; biological combination product; device; human factor study; pen; pre-filled syringe

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