Advances in analytical methods and bioequivalence assessment science have driven the evolution of bioequivalence recommendations for locally acting inhalation products toward option-based bioequivalence frameworks, incorporating innovative in vitro, in vivo, and in silico methods as viable alternatives to comparative clinical endpoint studies. These developments represent meaningful opportunities to modernize and strengthen the development and approval of generic inhalation products. As with any emerging methodology, their novelty may give rise to questions where additional clarity could further support their implementation. This workshop will explore these opportunities with the goal of building shared understanding, refining best practices, reducing redundancies, and streamlining evaluations that will ultimately support more efficient generic development programs and timely approvals.
Attendees will gain valuable insights into the current understanding, regulatory expectations, and industry experiences with developing, validating, and using in vitro and in vivo methods included as part of bioequivalence recommendations for metered dose inhalers (MDIs) and dry powder inhalers (DPIs) without significant formulation differences with their reference standard (RS). The final session of the workshop will explore the potential for using innovative in vitro and in vivo methods in these option-based frameworks with products containing significant formulation differences with their RS. In addition to a series of expert-led presentations and panel discussions, in-person attendees will interact directly with experts from industry, academia and regulatory agencies to better understand the current practices and considerations with conducting these studies.
The two-day workshop is designed to discuss in vitro methods for particle size distribution, dissolution and particle morphology; the current expectations and potential alternatives to charcoal block in vivo pharmacokinetic s