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Mesalamine is a locally-acting gastrointestinal drug, which can be absorbed into the systemic circulation. It's one of the first-class drugs for treating mild and moderate ulcerative colitis. Its plasma concentration-time curve reflects the locally acting effect of mesalamine; however, the commonly used pharmacokinetic parameters (AUC & Cmax) are insufficient to prove the bioequivalence of different preparations, due to the variation between different dosage forms, such as extended-release capsules, enteric-coated tablets, suppositories, and enemas. In this review, we summarizes the bioequivalence guidelines of different mesalamine preparations published by the U.S. Food and Drug Administration and European Medicines Agency. We also propose some suggestions for the bioequivalence standards of mesalamine based on the characteristics of its reference preparations in China.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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