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Eliglustat is a first-line oral small molecule drug for the treatment of type 1 Gaucher disease, which can reduce the volume of spleen and liver, and improve anemia and thrombocytopenia. Eliglustat is mainly metabolized by cytochrome P450 2D6 (CYP2D6), and its systemic exposure is significantly affected by CYP2D6 phenotypes. The bioavailability is extremely low in CYP2D6 extensive metabolizers, resulting in the bioequivalence (BE) study results being easily affected by factors other than the preparation itself. This paper analyzed the potential risk factors in the BE study of eliglustat capsules from the aspects of molecular characteristics, biopharmaceutics, pharmacokinetics, food-drug interaction and genetic polymorphism of metabolic enzymes, so as to provide a practical reference for the BE study of the generic research and development of this variety.
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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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