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Outline
Compared with ordinary preparations, inhalants have special characteristics in terms of dosage form, device and mode of action. If the bioequivalence evaluation of inhalation is carried out according to the evaluation method of ordinary preparations, the accuracy of obtained results may be reduced. The bioequivalence evaluation of inhalation is facing challenges. At present, with the increasing market demand, domestic researches on inhalation preparations have also shown an upward trend; however, no domestic guidelines for bioequivalence evaluation of inhalation have been formally issued, bringing certain limitations to related researches. This article mainly introduces the guidelines and revised drafts of bioequivalence evaluation of inhalation preparations by the drug regulatory agencies of the United States, Europe and Canada, compared with the public solicitation of “Guidelines for the Research on Guiding Principles of Oral Inhalation Formulation Generic Pharmaceuticals and Human Bioequivalence Research” which is issued in August 2019 by Center for Drug Evaluation of National Medical Products Administration of China. Combined with specific cases, this article provides a scientific reference for the bioequivalence research of inhalation 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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