Verification of the EDA Concept Through an Assessment of Theoretical Failure Modes, Failure Mode Analysis, and Case Stud
Previous chapters have presented the robust theoretical case for EDA in comparison with current ways of analyzing API mass distribution profiles from OIPs. This chapter is in two distinct parts; the first part examines from the theoretical standpoint, way
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Verification of the EDA Concept Through an Assessment of Theoretical Failure Modes, Failure Mode Analysis, and Case Studies with Real Data Helen Strickland, Beth Morgan, J. David Christopher, Volker Glaab, Adrian Goodey, Keyur Joshi, Lei Mao, and Jolyon P. Mitchell
Abstract Previous chapters have presented the robust theoretical case for EDA in comparison with current ways of analyzing API mass distribution profiles from OIPs. This chapter is in two distinct parts; the first part examines from the theoretical standpoint, ways in which changes in APSD could potentially go undetected by EDA; the second presents a series of case studies with a variety of OIP types that demonstrate the appropriateness of EDA as a powerful, yet simple-to-use tool for in vitro assessment of CI data. Discussion of theoretical failure modes is presented for general awareness. In a given product/method development, each sponsor would have to conduct their own analysis of potential failure modes based on their situation. Similarly, the case studies are presented as illustrations of EDA and AIM applications for several real OIPs. Each sponsor may develop a different way to implement AIM and EDA, depending on their purpose.
H. Strickland () GlaxoSmithKline, N226, 1011 North Arendell, Zebulon, NC 27597, USA e-mail: [email protected] B. Morgan GlaxoSmithKline, Zebulon Manufacturing and Supply, 1011 N. Arendell Avenue, Zebulon, NC 27597, USA e-mail: [email protected] J.D. Christopher Nonclinical and Pharmaceutical Sciences Statistics, Merck Research Laboratories, WP37C-305, 770 Sumneytown Pike, 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] A. Goodey Merck & Co. Inc., 556 Morris Ave, Summit, NJ 07901, 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_9, © Springer Science+Business Media New York 2013
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Introduction
EDA, being a new concept, will require a period of time to allow for confidence building, based on the experience of individual organizations involved with the OIP life cycle. The acceptance by regulators that this approach is valid, whether approached simply using one of the existing compendial full-resolution CIs or augmented by measurements obtained with an appropriately validated AIM-based apparatus, will require a body of validated evidence in which all possible scenarios that might result in failure have been assessed. This chapter begins the process of acceptance by looking at the EDA concept from two different viewpoints: 1. Theoretical considerations, probing the EDA approach beyond conditions that are likely in association with currently marketed OIPs, by considering hypothetical scenarios in which this methodology might fail to have sufficient discriminating power to detect APSD c
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