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Lidocaine and Prilocaine Cream is a topical cream preparation made by a eutectic mixture of lidocaine and prilocaine in a ratio of 1∶1 by weight. Lidocaine and prilocaine are amide-type local anesthetic agents. Both lidocaine and prilocaine stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action. It is clinically used mainly for local anesthesia of the skin for punctures and superficial surgical procedures. Considering this product is a topical preparation, when evaluating its quality and efficacy consistency with the reference preparation, a stepwise comparative study be conducted based on the drug's characteristics, including pharmaceutical, nonclinical, and/or necessary clinical comparative studies, to support the equivalence evaluation of the generic drug the reference preparation. Clinical comparative studies of this product can be human bioequivalence (BE) studies with the reference preparation. In BE studies, the study type, dose and method of administration, application time, PK blood sampling, skin reaction observation, bioequivalence evaluation, and reactivity evaluation should be fully considered and reasonably designed. This article, based on the characteristics of Lidocaine and Prilocaine Cream and the BE study examples before the domestic launch of the same variety of generic drugs, systematically explores the general design requirements and related considerations for the bioequivalence study of 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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