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.

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

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

European Regulatory Developments for Orally Inhaled and Nasal Drug Products.  Santos, C., Marco, G., Nagao, L.M. et al. AAPS PharmSciTech October 2018, Volume 19, Issue 7, pp 3134–3140 (2018).

The Application of Abbreviated Impactor Measurement and Efficient Data Analysis in the Lifecycle of an Orally-Inhaled Product: A Roadmap Adrian P Goodey, Terrence Tougas, J David Christopher, William Doub, Svetlana Lyapustina, Jolyon P Mitchell.  PharmForum 44(4) USP Stimuli Article. 2018.

Plume Geometry Testing Relevance and Methodology: An IPAC-RS Survey. Frank Chambers, Samiran De, Sherryl Baxter, Adrian Parkinson, Bill Doub, Iain Breakwell, Manfred Fischer, and Lee M. Nagao. RDD 2018, Volume 2, 2018: 437-442.

Performance of the Population Bioequivalence (PBE) Statistical Test Using an IPAC-RS Database of Delivered Dose from Metered Dose Inhalers. Beth Morgan,  Stephanie Chen,  David Christopher,  Göran Långström,  Christopher Wiggenhorn,  Elise Burmeister Getz,  Hayden Beresford,  Thomas Hoffelder,  Daniela Acerbi,  Steven Andrews,  Mark Berry,  Monisha Dey, Joshi Keyur, Mary McKenry,  Marisa Pertile,  Helen Strickland,  David Wilcox,  Svetlana Lyapustina  AAPS PharmSciTech. 2018 Apr;19(3):1410-1425. doi: 10.1208/s12249-017-0941-8. Epub 2018 Feb 12.

2018

An Update on the activities of IPAC-RS. Andy Rignall, Lee Nagao and Svetlana Lyapustina. Inhalation Magazine. November 2017. 

Highlights from the 2017 IPAC-RS/ISAM Joint Workshop “New Frontiers in Inhalation Technology” Smyth Hugh D., Colthorpe Paul, George Maureen, Jansen Paul, Fuglsang Anders, Armstrong Katherine E., and Lyapustina Svetlana. Journal of Aerosol Medicine and Pulmonary Drug Delivery. November 2017, ahead of print.

Discriminating Ability of Abbreviated Impactor Measurement Approach (AIM) to Detect Changes in Mass Median Aerodynamic Diameter (MMAD) of an albuterol/salbutamol pMDI aerosol. J. David Christopher,  Rajni B. Patel,  Jolyon P. Mitchell, Terrence P. Tougas,  Adrian P. Goodey, Jorge Quiroz, Patrik U. Andersson, Svetlana Lyapustina. AAPS PharmSciTech, 2017.  doi:10.1208/s12249-017-0814-1.  Available for onscreen reading here.

Recommended Baseline Requirements for Materials used in Orally Inhaled and Nasal Drug Products (OINDP) IPAC-RS, 2017. The IPAC-RS OINDP Materials Working Group hosted an IPAC-RS Supplier and Pharma Workshop on Device and Container Closure System Quality on November 8, 2018 in Washington, DC.  The Workshop goals were:  1) to discuss and obtain feedback on the concepts and application of the IPAC-RS Baseline Requirements document, 2) identify areas where IPAC-RS, in partnership with suppliers, may drive forward activities of value to both product manufacturers and the supply community, and 3) educate and share knowledge on what it takes to ensure material and component quality.

Human Factors Engineering (HFE): Patient-Centric Product Design.  Summary of the Podium Talks and Panel Discussion in the HFE Session of the IPAC-RS Symposium.  IPAC-RS. 2017.  

2017

© 2020 IPAC-RS