Future Directions for the AIM and EDA Concepts

  • Terrence P. Tougas
  • Jolyon P. Mitchell


The abbreviated impactor measurement (AIM) and efficient data ­analysis (EDA) concepts have both been presented in detail in previous chapters of this book, based on the knowledge acquired by the middle of 2012. It is recognized that both issues have attracted much interest from stakeholders involved with the in vitro testing of OIPs, and so the likelihood of further significant developments in the next few years is very strong. This chapter therefore starts by looking at questions that were raised at a special symposium in the spring of 2011, at which representatives from industry, academia, compendial committees, and regulatory agencies had the opportunity to air their views on these topics, with some speculation on likely future developments. The remainder of the chapter considers some ideas about further use of both AIM and EDA concepts.


Product Lifecycle Management Aerodynamic Particle Size Distribution Abbreviate Impactor Measurement Anderson Cascade Impactor Efficient Data Analysis 
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  1. 1.
    IPAC-RS (2011) Satellite conference at RDD-Europe 2011: Perspectives on Efficient Data Analysis methods and Abbreviated Impactor Measurements as quality assessment tools. Presentations and Summary Report. Available at: Accessed 27 Jan 2012
  2. 2.
    Tougas T (2011) Lifecycle aspects of incorporating AIM-EDA into development cycle: Q&A Technical aspects presented at satellite conference at RDD-Europe 2011: Perspectives on efficient data analysis methods and abbreviated impactor measurements as quality assessment tools. Presentations and Summary Report. Available at: Accessed 27 Jan 2012
  3. 3.
    Efficient data analysis, abbreviated impactor measurements, aerodynamic particle size distributions: publications and presentations by members of the IPAC-RS Cascade Impaction Working Group and EPAG (2011). Available at: Accessed 27 Jan 2012
  4. 4.
    Christopher D, Dey M, Lyapustina S, Mitchell J, Tougas T, Van Oort M, Strickland H, Wyka B (2010) Generalized simplified approaches For MMAD determination. Pharm Forum 36(2):812–823Google Scholar
  5. 5.
    Mitchell J, Tougas T, Christopher JD, Lyapustina S (2010) Extension of the Abbreviated Impactor Measurement (AIM) concept to incorporate simultaneous determination of Delivered Dose Uniformity with Efficient Data Analysis metrics pertinent to aerodynamic particle size (AIM-DDU Apparatus). Drug Delivery to the Lungs-21, The Aerosol Society, Edinburgh, 221–214. Available at: Visited 4 Aug 2012
  6. 6.
    Garmise RJ, Hickey AJ (2008) Calibration of the Andersen cascade impactor for the characterization of nasal products. J Pharm Sci 97(8):3462–3466PubMedCrossRefGoogle Scholar
  7. 7.
    Marple VA, Olson BA, Santhanakrishnan K, Roberts DL, Mitchell JP, Hudson-Curtis BL (2004) Next generation pharmaceutical impactor. Part III: Extension of archival calibration to 15 L/min. J Aerosol Med 17(4):335–343PubMedCrossRefGoogle Scholar
  8. 8.
    Bowles N, Cahill E, Häberlin B, Jones C, Mett I, Mitchell J, Müller-Walz R, Musa R, Nichols S, Parkins D, Pettersson G, Preissmann A, Purewal T, Schmelzer C (2007) Application of quality by design to inhalation products. In: Dalby RN, Byron P, Peart J, Suman JD (eds) Respiratory drug delivery-Europe 2007. Davis Healthcare International Publishing LLC, River Grove, IL, pp 61–69Google Scholar
  9. 9.
    US Food and Drug Administration (FDA) (2006) Guidance for industry: quality systems approach to pharmaceutical CGMP regulations. Rockville, MD. Accessed 26 June 2012 at: Accessed 6 Sep 2012
  10. 10.
    European Medicines Agency (EMA) (2011) EMA-FDA pilot program for parallel assessment of quality by design applications. EMA/172347/2011, London. Available at: Accessed 26 June 2012

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  1. 1.Boehringer Ingelheim Pharmaceuticals Inc.RidgefieldUSA
  2. 2.Trudell Medical InternationalLondonCanada

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