Product Life Cycle Approach to Cascade Impaction Measurements
Over the OIP life cycle (from development to commercial production, to the development of generic/follow-on products), APSD measurements are used extensively but for different purposes. The analytical and statistical approaches to the measurements and dat
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Product Life Cycle Approach to Cascade Impaction Measurements Richard Bauer, J. David Christopher, Volker Glaab, Svetlana A. Lyapustina, Jolyon P. Mitchell, and Terrence P. Tougas
Abstract Over the OIP life cycle (from development to commercial production, to the development of generic/follow-on products), APSD measurements are used extensively but for different purposes. The analytical and statistical approaches to the measurements and data analyses at these stages must therefore be different, depending on the specific questions pursued in a given situation. For some of those questions, full-resolution CIs are the instrument of choice. For others, an AIM system can provide all the needed information and support decision-making. This chapter describes how the utilization of specific measurement approaches changes
R. Bauer MannKind Corporation, Aerosol Analysis, One Casper Street, Danbury, CT 06810, USA e-mail: [email protected] J.D. Christopher Merck Research Laboratories, Nonclinical and Pharmaceutical Sciences Statistics, 770 Sumneytown Pike, WP37C-305, West Point, PA 19486-0004, USA e-mail: [email protected] V. Glaab Boehringer Ingelheim, Respiratory Drug Delivery, Binger Strasse 173, Ingelheim am Rhein 55216, Germany e-mail: [email protected] S.A. Lyapustina, Ph.D. Drinker Biddle & Reath LLP, 1500 K Street NW, Washington, DC 20005-1209, 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 () Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877-0368, USA 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_6, © Springer Science+Business Media New York 2013
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over the product life cycle, and how the entire body of APSD data is interlinked to enable those transitions (e.g., by establishing correlations or by establishing typical profile parameters), thereby enhancing product knowledge, appropriate control, and comparisons between innovator and generic OIPs.
6.1
Choosing an AIM System Suitable for Purpose
The reasons for making APSD measurements vary throughout the product life cycle, as has been described in detail in Chap. 5, and a summary of the goals and recommended CI system for different life cycle stages was presented in Table 5.2. These considerations include discovery and screening of early candidate formulations, followed by development and characterization of lead candidates, introduction of the technique for QC in commercial production, and finally, demonstration of in vitro equivalence for modified versions of the original OIP or follow-on (generic) copies of the product. At each of the life cycle stages, a suitable APSD measurement system, together with data analysis procedure, must be employed, while appropriate continuity should be built in, to allow the
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