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.
2023
An Overview and Discussion of N-nitrosamine Considerations for Orally Inhaled Drug Products and Relevance to Other Dosage Forms. AAPS PharmSciTech (January 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)
2022
An update from the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) Inhalation Magazine (December 2022)
Moving Forward from "Fine Particle Fraction: The Good and the Bad" (August 2022) Journal of Aerosol Medicine and Pulmonary Drug Delivery, 35(4), pp. 225–226
Spray Pattern and Plume Geometry Testing and Methodology: An IPAC-RS Working Group Overview. (May 2022) AAPS PharmSciTech 23, 145.
IPAC-RS Summary of Global Regulatory Developments 2021 (April 2022) 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 2021.
IPAC-RS Year in Review 2021
Efficient Data Analysis (EDA): Size, Mass and Common Sense Inhalation Magazine (August 2021)
Performance of Multiple-Batch Approaches to Pharmacokinetic Bioequivalence Testing for Orally Inhaled Drug Products with Batch-to-Batch Variability AAPS PharmSciTech 22: 225 DOI: 10.1208/s12249-021-02063-1 (August 2021)
IPAC-RS Regulatory Roundtable Series: A conversation with the US FDA: Perspectives in the time of COVID-19 Inhalation Magazine (June 2021)
IPAC-RS Summary of Global Regulatory Development 2020 (May 2021)
2021
2020
IPAC-RS Year in Review 2020
IPAC-RS Position Paper on pMDI as Non-Active Medical Device (2020)
Addressing the Need for Controls on Particle Bounce and Re-entrainment in the Cascade Impactor and for the Mitigation of Electrostatic Charge for Aerodynamic Particle Size Assessment of Orally Inhaled Products: An Assessment by the International Consortium on Regulation and Science (IPAC-RS). William Doub, Stephen Stein, Jolyon Mitchell, Adrian Goodey. AAPS PharmSciTech 21, Article number: 239 (August 2020)
Evaluation of the Sensitivity and Robustness of Modified Chi-Square Ratio Statistic for Cascade Impactor Equivalence Testing Through Monte Carlo Simulations. Abhinav Kurumaddali, David Christopher, Helen Strickland, Beth Morgan, Christopher Wiggenhorn, Stephen Stein, Svetlana Lyapustina & Günther Hochhaus. AAPS PharmSciTech; vol. 21, Article number: 147 (May 2020)
Posters at the Joint Virtual IPAC-RS RDD 2020 Symposium (April 2020)
The Liability of Fine Particle Dose (FPD) Can We Rely on Fine Particle Dose Metric Alone for Quality Control? Adrian P. Goodey, Jolyon P. Mitchell, William H. Doub & J. David Christopher. Inhalation magazine. April 2020 issue.
Reflections on Digital Health Tools for Respiratory Applications. Andy Dundon, David Cipolla, Jolyon Mitchell, and Svetlana Lyapustina. Journal of Aerosol Medicine and Pulmonary Drug Delivery (Published Online: 16 Mar 2020).
2019
IPAC-RS Year in Review 2019
Performance of the Population Bioequivalence (PBE) Statistical Test with Impactor Sized Mass Data AAPS PharmSciTech (2019) 20:296. DOI: 10.1208/s12249-019-1507-8 Stephanie Chen, Beth Morgan, Hayden Beresford, Elise Burmeister Getz, David Christopher, Göran Långström, Helen Strickland, Christopher Wiggenhorn, and Svetlana Lyapustina.
Overview of Brazilian Requirements for Therapeutic Equivalence of Orally Inhaled and Nasal Drug Products. Marcia Silva, Helena Costa, Bruna Nardy, Lee Nagao, Gustavo Mendes Lima Santos. AAPS PharmSciTech August 2019, 20:235
Determination of Passive Dry Powder Inhaler Aerodynamic Particle Size Distribution by Multi-Stage Cascade Impactor: International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) Recommendations to Support Both Product Quality Control and Clinical Programs. Jolyon P. Mitchell, Stephen W. Stein, William Doub, Adrian P. Goodey, J. David Christopher, Rajni B. Patel, Terrence P. Tougas Mitchell, J.P., Stein, S.W., Doub, W. et al. AAPS PharmSciTech (2019) 20: 206.
Cascade Impactor Equivalence Testing: Comparison of the Performance of the modified Chi-Square Ratio Statistic (mCSRS) with the original CSRS and EMA’s Average Bioequivalence Approach. Abhinav Kurumaddali, David Christopher, Dennis Sandell, Helen Strickland, Beth Morgan, Juergen Bulitta, Christopher Wiggenhorn, Stephen Stein, Svetlana Lyapustina, Günther Hochhaus. doi:10.1208/s12249-019-1443-7 AAPS PharmSciTech; 2019;20:249; 1–17.
An IPAC-RS Overview. Inhalation, Feb 2019, Also available here.
