2019
DOI: 10.1007/s13318-019-00561-z
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Current Understanding of the Equivalence Evaluations for In Vitro Tests on Generic Dry Powder Inhaler Drug Products in Japan

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Cited by 5 publications
(3 citation statements)
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“…Japan's pharmaceutical and medical devices agency (PMDA) has announced fundamental principles for the bioequivalence assessment of inhalers in 2016. This agency indicated the three-stage evaluation for developing inhalation products, including in vitro studies, PK reports, and clinical endpoint studies, the same as FDA steps (71,81). It delineated the significance of the delivered dose in line with fine particle mass and at least four sets of stages at three flow rates (10th, 50th, and 90th percentiles; e.g., 30 l/min, 60 l/min, and 90 l/min) in in vitro tests to confirm bioequivalence (81).…”
Section: Figure 1 the Advantages And Disadvantages Of Ebc Analysismentioning
confidence: 99%
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“…Japan's pharmaceutical and medical devices agency (PMDA) has announced fundamental principles for the bioequivalence assessment of inhalers in 2016. This agency indicated the three-stage evaluation for developing inhalation products, including in vitro studies, PK reports, and clinical endpoint studies, the same as FDA steps (71,81). It delineated the significance of the delivered dose in line with fine particle mass and at least four sets of stages at three flow rates (10th, 50th, and 90th percentiles; e.g., 30 l/min, 60 l/min, and 90 l/min) in in vitro tests to confirm bioequivalence (81).…”
Section: Figure 1 the Advantages And Disadvantages Of Ebc Analysismentioning
confidence: 99%
“…This agency indicated the three-stage evaluation for developing inhalation products, including in vitro studies, PK reports, and clinical endpoint studies, the same as FDA steps (71,81). It delineated the significance of the delivered dose in line with fine particle mass and at least four sets of stages at three flow rates (10th, 50th, and 90th percentiles; e.g., 30 l/min, 60 l/min, and 90 l/min) in in vitro tests to confirm bioequivalence (81). Furthermore, the PMDA takes into account clinical population variance based on various stages of lung disease that could be resolved using in vitro tests (81).…”
Section: Figure 1 the Advantages And Disadvantages Of Ebc Analysismentioning
confidence: 99%
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