Publications

IPAC-RS strives to share with the wider scientific and regulatory community the knowledge and insights created through its work, via publications in peer-reviewed journals. A complete publication list is accessible here.

2025

Inhalable and Nasal Biologics: Analytical, Formulation, Development, and Regulatory Considerations. Journal of Aerosol Medicine and Pulmonary Drug Delivery (April 2025)

Materials Compatibility Considerations for the Transition to Low Global Warming Potential Propellants for Pressurized Metered Dose Inhalers AAPS PharmSciTech 26, 65 (2025).

Newsletter

Presentations

Comments on Guidances

Reference Links

2024

IPAC-RS Year in Review 2024

IPAC-RS Scenarios – Transition to LGWP Propellants in MDIs: Proposed Pathway to US FDA Approval (Nov 2024, IPAC-RS website)

Point of view: A better way to set specifications and control quality—general concepts and examples. An opinion article by representatives of the IPAC-RS Product Quality Demonstration Strategy (PQDS) Working Group. Helen Strickland; J. David Christopher; Beth Morgan; Greg Larner, and Svetlana Lyapustina. Inhalation Magazine. October 2024.

Regulatory Topics in Nasal Product Development: Pediatrics and Reliability Expectations. Gibbons A, Gold L, Hosseini S, Jordan L, Lyapustina S, Mccarry P, Perriolat JN, Silva L, Vincey RD, Wilcox D. Respiratory Drug Delivery 2024: 283-290.

IPAC-RS: An Update and Review of 2023. Mike Needham, Jen Wiley, Mary Kate Bielinski. Inhalation Magazine, February 2024.

IPAC-RS Summary of Global Regulatory Developments 2023 (March 2024). IPAC-RS engages actively in reviewing and commenting on regulatory developments around the world, and works collaboratively with all stakeholders to improve science-based regulations affecting orally inhaled and intranasal pharmaceutical products. IPAC-RS prepared a summary of relevant global regulatory developments in 2023.

2023

IPAC-RS Year in Review 2023

Biocompatibility Considerations for Orally Inhaled and Nasal Drug Products and other Drug Device Combination Products PDA Journal of Pharmaceutical Science and Technology (November 2023)

Laboratory Performance Testing of Aqueous Nasal Inhalation Products for Droplet/Particle Size Distribution: an Assessment from the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) AAPS PharmSciTech (October 2023)

Limitations of metrics used in the regulation of aerodynamic particle size distributions (APSDs) of orally inhaled products (OIPs) - An interview with Adrian Goodey of the IPAC-RS Cascade Impaction Working Group on reactions in the inhaler community to a series of published articles Inhalation Magazine (October 2023)

Good Practices for the Laboratory Performance Testing of Aqueous Oral Inhaled Products (OIPs): An Assessment from the International Consortium on Regulation and Science (IPAC-RS). AAPS PharmSciTech (March 2023)

An Overview and Discussion of N-nitrosamine Considerations for Orally Inhaled Drug Products and Relevance to Other Dosage Forms. AAPS PharmSciTech (January 2023)

IPAC-RS Summary of Global Regulatory Developments 2022 (August 2023) IPAC-RS engages actively in reviewing and commenting on regulatory developments around the world, and works collaboratively with all stakeholders to improve science-based regulations affecting orally inhaled and intranasal pharmaceutical products. IPAC-RS prepared a summary of relevant global regulatory developments in 2022.