Future Directions for the AIM and EDA Concepts
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 attr
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Future Directions for the AIM and EDA Concepts Terrence P. Tougas and Jolyon P. Mitchell
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.
13.1
Questions Arising from the IPAC-RS-Sponsored Conference: “Perspectives on Efficient Data Analysis Methods and Abbreviated Impactor Measurements as Quality Assessment Tools”
IPAC-RS hosted a satellite conference on Friday, 6 May 2011 at Respiratory Drug Delivery Europe 2011, which included short presentations from representatives of regulatory agencies, pharmacopeias, and industry. These presentations were followed
T.P. Tougas () Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877-0368, USA e-mail: [email protected] J.P. Mitchell Trudell Medical International, 725 Third Street, London, ON N5V 5G4, Canada e-mail: [email protected] T.P. Tougas et al. (eds.), Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products, DOI 10.1007/978-1-4614-6296-5_13, © Springer Science+Business Media New York 2013
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by interactive discussions with the audience around technical and statistical aspects of EDA and AIM and the lifecycle approach to incorporating EDA and AIM in product development, registration, and manufacturing. The presentations and a summary report are posted on the IPAC-RS public website [1]. At the outset, it is important to note that the conference mandate was on the application to OIP quality control, so issues concerning the potential application of AIM to the acquisition of more clinically appropriate data, discussed in Chap. 12, were not discussed. Responses to the first group of questions came from the panelists covering the topic Technical Aspects of EDA and AIM: Incorporating EDA and AIM into the Development Cycle. Editorial comments are inserted between parentheses “[]” where needed for clarity, and some responses have added interpretation, based on information located elsewhere in this book. 1. Would we need a separate impactor for each product? No, we need only a couple of different cut points for the boundary between large and small particles, because the EDA method is robust with respect to shifts of the boundary (in the studied example presented
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