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Acetylcysteine is a commonly used clinical drug, and its free thiol group can break the disulfide bond (S-S) in the glycoprotein peptide chain in sputum, thereby reducing sputum viscosity and promoting sputum excretion. It is an endogenous substance. When conducting bioequivalence studies, it is necessary to fully consider and design aspects such as the research type, dosage, blood collection point design, bioequivalence evaluation, etc., and fully evaluate the impact of endogenous acetylcysteine on bioequivalence evaluation. This article integrates the pharmacokinetic (PK) characteristics of acetylcysteine granules along with the bioequivalence research conducted on its generic version prior to domestic marketing. Through this approach, it comprehensively explores the general design requirements and key considerations for conducting bioequivalence studies on this product.
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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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