Advancing BE Frameworks for Inhalation Drug Products: Optimizing Methods
About this Event
With the transition of bioequivalence recommendations for locally acting inhalation products to option-based frameworks, new in vitro, in vivo, and in silico methods have been incorporated that can serve as alternatives to comparative clinical endpoint studies. These new methods can present complex challenges for their development and conduct, which may affect the timing for generic product development and assessment. This workshop will explore these challenges with the goal of identifying potential strategies to enhance study development, eliminate redundancies, and streamline evaluations to minimize review cycles while also exploring pathways for generic products with compositional differences relative to the reference listed drug.
The two-day workshop is designed to discuss and understand the challenges and recommendations related to 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 to identify areas where reduced study recommendations may offer ways to streamline abbreviated new drug application (ANDA) submissions.
Agenda
D1 S1: Current Bioequivalence Approaches for Inhalation Drug Products
Info: 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
Info: 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
Info: 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.
D1 S4: Expectations and Opportunities with Particle Morphology Testing
Info: Presentations and Panel Discussion (in person and virtual): This session examines the FDA expectations and industry experience with particle morphology characterization studies. Speakers will cover topics on purpose of utility of particle morphology characterization across inhalation products, current and alternative methods for morphology characterization, and considerations and challenges with multi-component formulations.
D1 S5: Open Exchange (in person only)
Info: Interactive Discussions on Focused Product Development and Assessment Areas (in person only): This session is dedicated to interactive discussions and candid dialogue with FDA, Industry, Academic, and other subject matter experts about scientific and regulatory challenges for complex inhalation generic products.
D2 S6: Small Group Working Session (in person only)
Info: Interactive Working Session (in person only): In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, and academic experts. In-person attendees will engage in guided discussions and exercises related to Sessions 2-4, building consensus, and reporting of actionable research or recommendations. The outcome of this session will be a meeting report summarizing key discussion points, consensus findings, and emerging recommendations , which will be shared publicly after the workshop.
D2 S7: Waivers for In Vitro & In Vivo PK Studies– Challenges & Opportunities
Info: Presentations and Panel Discussion (in person and virtual): This session explores the considerations and challenges with the recommended in vivo PK BE studies, including more complex designs like charcoal-block studies. Speakers will cover topics related to the rationales for current recommendations, implications and experiences from industry, and where alternative methods like in silico modeling may have potential for improving efficiency.
D2 S8: Moving Beyond Formulation Sameness
Info: Presentations and Panel Discussion (in person and virtual): The final hybrid session focuses on the implications of formulation sameness recommendations for inhalation products. Speakers will cover topics on the role of formulation sameness with inhalation products based on current scientific understanding, along with potential opportunities for moving beyond these recommendations through improved understanding of the critical factors governing product performance.
Where is it happening?
Event Location & Nearby Stays:
USD 0.00 to USD 350.00
