Combination product testing questions

What is combination product testing?

Combination products deliver biologics and other pharmaceutical agents accurately and dependably to the point of need. Validation and batch testing for these systems examine those properties. Is the dose delivered accurately as intended without any extraneous material? Studies therefor revolve around stability, chemical migration and mechanical performance. That performance can include diffusion across membranes, particle generation, liquid dose volumes, dissolution, user interaction and many other aspects.

Are human factors studies required for combination devices?

Drug delivery combination products can be convenient, accurate and targeted. They can save time in clinics and help avoid clinical errors. They are also subject to in use errors. Human factors studies are required to assess the effectiveness of instructions and markings, the handling and application of the device, in summary the scope for avoidable errors. Studies should be designed to test the representative user interaction, in the possible environments of use and use the information garnered to deliver safe and effective outcomes.

How are combination products regulated?

EMA draft guidance (EMA/CHMP/QWP/BWP/259165/2019) was published for consultation in the summer of 2019 with a planned final publication date of 26 May 2020.

The American Food and Drug Administration (FDA) applies the pre-market review of combination products through its Office of Combination Products (OCP). Here medical a device is not necessarily included in the combination product. It could comprise two therapeutic materials (drug/biologic).

All regulatory authorities will want to see evidence drug dosages are accurately administered from a device which is not harmful and is stable throughout its life



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