Skip to main content

Abstract

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.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 129.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 169.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 169.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  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: http://www.ipacrs.com/CI.html. Accessed 27 Jan 2012

  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: http://www.ipacrs.com/CI.html. Accessed 27 Jan 2012

  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: http://www.ipacrs.com/CI.html. Accessed 27 Jan 2012

  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):812–823

    Google Scholar 

  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: http://ddl-conference.org.uk/index.php?q=previous_conferences. Visited 4 Aug 2012

  6. Garmise RJ, Hickey AJ (2008) Calibration of the Andersen cascade impactor for the characterization of nasal products. J Pharm Sci 97(8):3462–3466

    Article  PubMed  CAS  Google Scholar 

  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):335–343

    Article  PubMed  Google Scholar 

  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 61–69

    Google Scholar 

  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: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070337.pdf. Accessed 6 Sep 2012

  10. European Medicines Agency (EMA) (2011) EMA-FDA pilot program for parallel assessment of quality by design applications. EMA/172347/2011, London. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/03/WC500103621.pdf. Accessed 26 June 2012

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Terrence P. Tougas .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2013 Springer Science+Business Media New York

About this chapter

Cite this chapter

Tougas, T.P., Mitchell, J.P. (2013). Future Directions for the AIM and EDA Concepts. In: Tougas, T., Mitchell, J., Lyapustina, S. (eds) Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products. Springer, Boston, MA. https://doi.org/10.1007/978-1-4614-6296-5_13

Download citation

Publish with us

Policies and ethics