Features

DDL 2024 drew the largest crowd ever in the 35-year history of the Drug Delivery to the Lung (DDL), with more than 100 OINDP experts attending online and approximately 1,000 attending in person at the Edinburgh International Conference Centre. DDL celebrated its anniversary with a gala dinner, timely podium and poster presentations, and a sold-out exhibition. Hot … [Read more...] about DDL 2024 in review

The annual Drug Delivery to the Lungs (DDL) conference will mark its 35th anniversary during this year's meeting, which will take place December 11-13 at the Edinburgh International Conference Centre (EICC). Organizers have set a registration deadline of Sunday, November 10 to assist them in finalizing plans for a gala dinner celebrating the 35th anniversary. The … [Read more...] about DDL 2024 to celebrate 35 years as a leading OINDP conference

A striking feature of recent batches of OINDP product specific guidances (PSGs) is the inclusion of strategies for the demonstration of bioequivalence (BE) that eliminate the need for a clinical endpoint trial. Copley Applications Specialist Clair Brooks discusses evolving test methods within this context, notably realistic aerodynamic particle size distribution … [Read more...] about A Q&A with Copley’s Clair Brooks on alternative BE approaches in new FDA guidance

By Yvonne Limpens, Managing Human Factors Specialist at Emergo by UL While the time to market for generic inhalers is much shorter compared to novel inhalers because there is no requirement for generic product manufacturers to repeat clinical research on ingredients or dosage forms already approved for safety and effectiveness, one aspect often overlooked during … [Read more...] about Human Factors (HF) Considerations for Generic Inhalers Using Off-the-shelf Devices

RDD 2024, which took place May 5-9 in Tucson, AZ, USA, brought together more than 530 delegates and 70 exhibitors for a meeting that highlighted a number of transitions taking place in the development of OINDPs. Compared to past meetings, the 2024 edition of Respiratory Drug Delivery featured a large proportion of the presentations, posters, and exhibitors … [Read more...] about RDD 2024 highlighted an industry in transition

Kimberly Shepard is Director, Respiratory Delivery, at Lonza You presented a workshop at RDD 2023 subtitled, “From small molecules to all molecules” -- can all biotherapeutics really be spray dried for inhalation? Besides being a catchy title, “From small molecules to all molecules” captures the essence of what’s going on right now in the field of pharmaceutical … [Read more...] about Lonza’s Kimberly Shepard answers questions about spray drying biologics for inhalation

From May 5-9, RDD 2024 will welcome an international gathering of OINDP experts to the JW Marriott Starr Pass Resort and Spa in Tucson, AZ, which previously hosted RDD 2018. According to Richard Dalby of RDD Online, registration for the meeting so far has been strong, with a higher-than-usual contingent of delegates from outside of North America and Europe … [Read more...] about RDD 2024 to cover the latest OINDP development trends

Copley Application Specialist Clair Brooks discusses new EMA guidance on data requirements associated with the transition to low global warming potential (LGWP) propellants in metered dose inhalers and strategies for the successful application of in vitro testing within this context. How does the 2023 EMA Q&A clarify data requirements for the LGWP transition … [Read more...] about Q&A with Copley’s Clair Brooks on in vitro testing for LGWP MDI reformulation