%0 Journal Article
%T Pre-ANDA strategy and Human Factors activities to de-risk pharmaceutical companies ANDA submission of drug-device combination products: case study of a formative Comparative Use Human Factors study.
%A Brunet-Manquat L
%A Combedazou A
%A Ahuja B
%A Maden A
%A Ramus C
%A Mardovina T
%A Frolet C
%J Expert Opin Drug Deliv
%V 21
%N 5
%D 2024 May 29
%M 38753579
%F 8.129
%R 10.1080/17425247.2024.2356678
%X <B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.<BR><B>UNASSIGNED: </B>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.