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Outline
Transdermal products have become the research focus for generic pharmaceutical preparations due to their unique advantages relative to other dosage forms and routes of administration. As a result of the complexity of transdermal formulations the bioequivalence study often faces more challenges. Bioequivalence of transdermal patches requires demonstration of pharmacokinetic equivalence along with adhesion studies, skin irritation and sensitization studies and residual analysis of the patch after the intended duration of application, for which domestic authorities have not issued recommendations. This paper provides an overview of the patches approved in global market and systematically expounds general principles for the designing, conducting and evaluating of bioequivalence study of transdermal patches based on guidances addressed by regulatory authorities worldwide and related literatures, which would be referential for domestic sponsors to carry out bioequivalence research of transdermal patches.
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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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