AIM and EDA concepts were developed to address the high variability and susceptibility to error of the conventional full-resolution CI methods in OIP quality control. Abbreviated measurements allow increased throughput during product development and routine quality control testing. Efficient data analysis simplifies data analysis (by using only two metrics for making decisions about presence or absence of APSD changes while in most cases, reducing the rate of false-positive and false-negative decisions). Each of these aspects is explored in more detail in later chapters. This chapter presents an overall rationale for the development of these alternative approaches, with emphasis placed on how they could fit into the OIP life cycle.
CITATION STYLE
Mitchell, J. P., & Tougas, T. P. (2013). The AIM and EDA concepts: Why they are needed and how they fit together. In Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products (Vol. 9781461462965, pp. 119–133). Springer US. https://doi.org/10.1007/978-1-4614-6296-5_5
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