Drug/Device and Device/Drug Combinations in the EU and USA

Apr 20th, 2015Apr 21st, 2015
London, H9
GB
http://www.management-forum.co.uk/pharmaceutical/events/drugdevice-devicedrug-combinations-eu-usa/
Phone:+44 (0) 1473 730071
Practical guidance on borderline issues and combination products.
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Emphysema progression with hole changes, with holes colored according to their diameter in 2-mm increments. (A) Baseline inspiratory nonenhanced axial CT scans in a 48-year-old man with chronic obstructive pulmonary disease show emphysema holes with hyperexpansion of secondary pulmonary lobules (white arrows) and thin alveolar walls visible in the right upper lobe. This emphysematous lesion is filled with holes of varying sizes. A single large air cyst was observed in the left upper lobe (black arrows), classified as a single emphysema hole of 20 mm or greater (bright green). (B) At six-year follow-up inspiratory nonenhanced axial CT, the holes in the right upper lobe have merged (white arrows), with no visible alveolar septa remaining, resulting in the formation of a large new hole of 20 mm or greater (bright green). Meanwhile, the hole in the left upper lobe also enlarged, merging with adjacent holes (black arrows). The size of other holes in the paramedian left upper lobe decreased.
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