Comparative Use Human Factors Study of a Manual vs. A Partially Automated Pen Injector for GLP-1 Receptor Agonist...

Area of Science:

• Pharmacology and Drug Delivery
• Human Factors Engineering
• Regulatory Science

Background:

• Injectable glucagon-like peptide-1 receptor agonists are often delivered via pen or autoinjectors.
• Emerging generic alternatives necessitate evidence of therapeutic equivalence for regulatory approval (Abbreviated New Drug Application).
• Comparative use human factors studies are an FDA-accepted method to demonstrate device substitutability.

Purpose of the Study:

• To evaluate the substitutability of a proposed generic manual pen injector for a reference partially automated pen injector.
• To assess critical task performance and dose delivery success rates between the two devices.
• To provide evidence supporting therapeutic equivalence for regulatory submissions.

Main Methods:

• A randomized, two-period, two-sequence crossover study involving 100 adult patients experienced with partially automated pen injectors.
• Subjects performed critical tasks (dose selection, injection) with both the test manual device and the reference partially automated device across two simulated scenarios.
• Noninferiority testing with a prespecified 10% margin was used to analyze co-primary endpoints (use success rates).

Main Results:

• Both co-primary endpoints demonstrated noninferiority, with all confidence bounds below the 10% margin.
• Scenario 1 (0.6 mg dose selection): Both devices achieved 95% success rates.
• Scenario 2 (3 mg dose selection and injection): The reference device achieved 100% success, while the test device achieved 95% success.

Conclusions:

• The proposed generic manual pen injector demonstrated noninferior performance compared to the reference partially automated pen injector.
• The study provides evidence supporting the substitutability of the generic manual device for the reference device.
• These findings support the use of comparative human factors studies for Abbreviated New Drug Application approval of generic drug-device combination products.