Advancing BE Frameworks for Inhalation Drug Products: Optimizing Methods
This workshop will address the latest BE methods and associated challenges shaping the development of complex generic inhalation products.
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 studies; a look forward at opportunities to expand use of these bioequivalence approaches and areas for products with significant formulation differences from their RS.
Good to know
Highlights
- 21 hours 30 minutes
- In person
- Paid parking
- Doors at 7:15 AM
Refund Policy
Location
The Universities at Shady Grove
9630 Gudelsky Drive
Rockville, MD 20850
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Agenda
D1 S1: Current Bioequivalence Approaches for Inhalation Drug Products
Presentations (in person and virtual): This session details the Agency’s latest advancements in bioequivalence (BE) strategies recommended for inhalation products, their associated challenges, and opportunities for clarity and efficiency. Topics include the current option-based framework, recommended BE studies, method considerations, industry experiences and challenges, and future directions for research initiatives and additional guidance.
D1 S2: Revisiting Realistic Particle Size Distribution Study Designs/Analyses
Presentations and Panel Discussion (in person and virtual): This session examines the FDA expectations and industry experience with conducting conventional and realistic APSD studies. Speakers will cover topics such as selection and use of anatomical mouth-throat models and breathing profiles, approaches for statistical analyses, study size, capturing clinically relevant variability, bracketing approaches, and potential opportunities for addressing common challenges.
D1 S3: Expectations for Designing Sensitive Dissolution Methods
Presentations and Panel Discussion (in person and virtual): This session examines the FDA expectations and industry experience with dissolution studies. Speakers will cover topics on the rationale and utility of dissolution for inhalation products, method development and sample collection, validation, demonstrating sensitivity, approaches for statistical analysis, and applicability of biopredictive and/or biorelevant approaches.