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Outline
Lanthanum carbonate chewable tablets were approved as a phosphate binder indicated to reduce serum phosphate in patients with end stage renal disease by the US FDA in the year of 2004. Lanthanum carbonate is a gastrointestinal (GI) tract locally acting drug. The oral absorption of lanthanum carbonate is very low, so the conventional in vivo bioequivalence study with a pharmacokinetic (PK) endpoint is not feasible. The FDA recommended in vitro dissolution testing and phosphate binding studies to demonstrate bioequivalence of lanthanum carbonate preparations. Based on the literatures and guidance issued by FDA, this article discussed the in vitro phosphate binding research of lanthanum carbonate chewable tablets from the aspects of methodology, experimental design and data analysis, hoping to provide references for the development of the generic drugs.
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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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