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Inhalation OctOber 2023 11 and readily acknowledge the shortcomings of the status quo. at said, any actual progress towards regulatory acceptance is imperceptible, which is obviously frustrating. Inhalation: Why do you think that is? Adrian: ere may be multiple reasons, but ulti- mately, I think it's important for us to focus on what we can control. We can't force these groups to act, nor can we streamline their processes. What we can do is raise awareness of these issues within the orally inhaled and nasal drug product (OINDP) com- munity. If drug development teams choose not to change their practices, or regulators choose not to change their requirements, that's up to them. What we can do is ensure—through education and com- munication—that their decisions are not made in ignorance. To that end, we will of course continue our efforts to publish and present on this topic and we are also exploring the possibility of organizing a forum to facilitate dialogue among stakeholders. Inhalation: What advice or guidance would you offer to drug development teams facing this disconnect between scientific developments and regulatory expectations? Adrian: First of all, I'd say, "don't lose hope." It's really easy to get demoralized when regulation lags behind science. We (the Cascade Impaction working group of IPAC-RS) are frequently dismayed to find that authorities are either utterly unaware of our work or simply choose to ignore it. We just keep advocating for what makes sense to us, and that's basically what I would offer as advice to development teams. I believe that there are multiple ways to effect change and that industry has an opportunity to lead the way. e articles we published focused on the use of APSD metrics in the commercial Quality Con- trol environment, on making batch-disposition decisions based on differences in APSD. However, the appropriate choice and use of APSD metrics is important throughout the development of a product. e fundamental problem with stage groupings and fine particle dose is that they tell you so little about your product's performance. So, for example, if you were to rely on fine particle dose or stage groupings to guide formulation and process development, you could end up in a real mess. Scientists need clear, sensible feedback and that neces- sitates the use of other APSD metrics during devel- opment. Our hope is that more and more teams will monitor both size and mass throughout development and will ultimately propose size-based and mass- based APSD metrics at filing. We expect that as regu- lators encounter more and more real-world examples in which metrics are used to make sensible, rational

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