Abstract：
UNASSIGNED: This article presents a strategy that a Drug Delivery Device Developer (DDDD) has adopted to support Abbreviated New Drug Application (ANDA) submissions of drug-device combination products. As per the related FDA guidance, a threshold analysis should be compiled. If \'other differences\' between the Reference Listed Drug (RLD) and the generic drug devices are identified, a Comparative Use Human Factors (CUHF) study may be requested.
UNASSIGNED: The DDDD performed task analysis and physical comparison to assess the pen injector design differences. Then, a formative CUHF study with 25 participants simulating injections using both RLD and the generic pen injectors was conducted.
UNASSIGNED: After each participant completed four simulated injections, similar type and rates of use error between the RLD (0.70) and generic (0.68) pen injectors were observed.
UNASSIGNED: DDDDs can support pharmaceutical companies in the ANDA submission strategy of their drug-device combination product by initiating comparative task analysis and physical comparison of the device as inputs for the threshold analysis. If \'other differences\' are identified, a formative CUHF study can be performed. As shown in our case study, this approach can be leveraged to support the sample size calculation and non-inferiority margin determination for a CUHF study with the final combination product.
UNASSIGNED: The DDDD performed task analysis and physical comparison to assess the pen injector design differences. Then, a formative CUHF study with 25 participants simulating injections using both RLD and the generic pen injectors was conducted.
UNASSIGNED: After each participant completed four simulated injections, similar type and rates of use error between the RLD (0.70) and generic (0.68) pen injectors were observed.
UNASSIGNED: DDDDs can support pharmaceutical companies in the ANDA submission strategy of their drug-device combination product by initiating comparative task analysis and physical comparison of the device as inputs for the threshold analysis. If \'other differences\' are identified, a formative CUHF study can be performed. As shown in our case study, this approach can be leveraged to support the sample size calculation and non-inferiority margin determination for a CUHF study with the final combination product.
摘要：
■本文介绍了药物输送装置开发商（DDDD）采用的策略，以支持药物-装置组合产品的缩写新药申请（ANDA）提交。根据FDA相关指南，应编制阈值分析。如果确定了参考上市药物(RLD)和通用药物器械之间的“其他差异”,可能需要进行比较使用人为因素（CUHF）研究。
■DDDD进行了任务分析和物理比较，以评估笔式注射器设计的差异。然后，我们进行了一项形成性CUHF研究,其中25名参与者使用RLD和通用笔式注射器模拟注射.
■每位参与者完成四次模拟注射后，在RLD(0.70)和通用(0.68)笔式注射器之间观察到相似的类型和使用错误率.
■DDDD可以通过启动设备的比较任务分析和物理比较作为阈值分析的输入，支持制药公司在其药物-设备组合产品的ANDA提交策略中。如果识别出\'其他差异\',可以进行形成性CUHF研究。如我们的案例研究所示，这种方法可用于支持最终组合产品的CUHF研究的样本量计算和非劣效性确定.
■DDDD进行了任务分析和物理比较，以评估笔式注射器设计的差异。然后，我们进行了一项形成性CUHF研究,其中25名参与者使用RLD和通用笔式注射器模拟注射.
■每位参与者完成四次模拟注射后，在RLD(0.70)和通用(0.68)笔式注射器之间观察到相似的类型和使用错误率.
■DDDD可以通过启动设备的比较任务分析和物理比较作为阈值分析的输入，支持制药公司在其药物-设备组合产品的ANDA提交策略中。如果识别出\'其他差异\',可以进行形成性CUHF研究。如我们的案例研究所示，这种方法可用于支持最终组合产品的CUHF研究的样本量计算和非劣效性确定.
