| 徐飞.皮肤局部外用仿制药临床生物等效性评价策略的一般考虑[J].安徽医药,2026,30(10):2108-2114. |
| 皮肤局部外用仿制药临床生物等效性评价策略的一般考虑 |
| Consideration on clinical bioefficacy evaluation strategy of generic topical dermatologic drugs |
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| DOI：10.3969/j.issn.1009-6469.2026.10.038 |
| 中文关键词: 仿制药品 皮肤科用药 投药，皮肤 一致性评价 体内生物等效性 体外释放试验 体外透皮试验 |
| 英文关键词: Generic drug Dermatologic agents Administration, cutaneous Consistency evaluation In vivo bioequivalence In vitro release test In vitro permeation tes |
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| 中文摘要: |
| 目的 分析和探讨影响皮肤局部外用仿制药临床生物等效性(BE)策略的各种因素，以期为该类仿制药临床BE策略的最优选择提供一些借鉴和参考。方法 2023年11月至2024年12月进行该研究。系统考量制剂自身性质特性及国内药品注册法规的政策因素，对比该类仿制药相关临床BE策略，如豁免临床BE、以全身入血药代动力学参数为指标的生物等效性(PKBE)、以皮肤药代动力学参数为指标的生物等效性(皮肤PK-BE)、以皮肤药效学参数为指标的生物等效性(PD-BE)以及以临床终点疗效为指标的生物等效性(临床终点BE)等的优缺点。结果 该类仿制药临床BE策略受药物透皮性质、起效部位、药物存在状态和剂型的影响，这些性质不同，临床BE策略的选择亦有差异。此外，国内药品注册法规对仿制药的定义也存在3类仿制药和4类仿制药的区别，其对临床策略亦有影响。结论 皮肤局部外用仿制药BE策略的影响因素有多种，每一临床BE策略有其优缺点和适用条件，具体品种具体分析，便可找到科学、合理、经济的最佳临床BE策略。 |
| 英文摘要: |
| Objective To analyze and discuss the various factors affecting the clinical bioequivalence (BE) strategies for generic topi?cal dermatological drugs, so as to provide references and guidance for the optimal selection of BE strategies for such generic products.Methods The study was conducted from November 2023 to December 2024. The research systematically considered the intrinsic characteristics of formulations and policy factors stipulated by domestic drug registration regulations. Meanwhile, the strengths and weaknesses of multiple clinical BE strategies for this category of generics were compared. These approaches covered waiver of BE, bio?equivalence based on systemic pharmacokinetic parameters (systemic PK-BE), bioequivalence based on cutaneous pharmacokinetic pa?rameters (skin PK-BE), bioequivalence based on cutaneous pharmacodynamic parameters (skin PD-BE), and bioequivalence based on clinical endpoint efficacy (clinical endpoint BE).Results Selection of clinical BE strategies for such generics depended on transder?mal characteristics, action sites, API physical state and dosage forms, with distinct strategies adopted for different product profiles. Fur?thermore, the domestic drug registration classification defined generic drugs as class 3 or class 4 generics, which also affected the clini?cal strategy selection.Conclusions There are various factors that affect the BE strategy for topical application of generic drugs on the skin, every clinical BE strategy has unique pros, cons and applicable scopes. Customized assessment of each specific drug enables the selection of a scientific, reasonable and cost-effective BE scheme. |
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