皮肤局部外用仿制药研发和评价用参比制剂选择的一般考虑
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摘要
本文参考国内外相关技术指导原则及文献,结合国内外监管机构对皮肤局部外用仿制药(TDGDs)的评价要求,并通过阿昔洛韦乳膏的实例,分析该类药物参比制剂(RLDs)选择的审评考虑,以期为国内仿制药企业和监管机构提供参考。
Referring to the relevant technical guidelines and literatures,combined with the evaluation requirements to topical dermatologic generic drugs (TDGDs) from domestic and foreign regulatory agencies,and by taking the Acyclovir Cream (5%) as example,this review analyzes evaluation considerations on the selection of reference-listed drugs (RLDs) for equivalence assessment of TDGDs,in order to provide references for domestic generic drug enterprises and regulators.
Referring to the relevant technical guidelines and literatures,combined with the evaluation requirements to topical dermatologic generic drugs (TDGDs) from domestic and foreign regulatory agencies,and by taking the Acyclovir Cream (5%) as example,this review analyzes evaluation considerations on the selection of reference-listed drugs (RLDs) for equivalence assessment of TDGDs,in order to provide references for domestic generic drug enterprises and regulators.
引文
[1]SHAH VP,YACOBI A,RDULESCU F爦,et al.A science based approach to topical drug classification system(TCS)[J].Int JPharm,2015,491(1-2):21-25.
[2]FDA.Product-specific guidances for generic drug development.draft guidance on Acyclovir[EB/OL].[2016-12].https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm428195.pdf.
[3]郭涤亮,徐萍蔚,王亚敏.皮肤局部外用仿制药质量等同性评价的一般考虑[J].中国新药杂志,2018,27(18):2116-2120.
[4]EMA.Concept paper on the development of a guideline on quality and equivalence of topical products[EB/OL].[2015-04-22].http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500186088&mid=WC0b01ac058009a3dc.
[5]许鸣镝,牛剑钊,杨东升,等.欧盟仿制药参比制剂检索示例[J].中国新药杂志,2018,27(1):26-30.
[6]许鸣镝,牛剑钊,杨东升,等.欧盟仿制药参比制剂介绍[J].中国新药杂志,2017,26(24):2933-2936.
[7]R?DULESCU F爦,MIRON DS.Physicochemical characterization of Acyclovir topical semisolid dosage forms towards TCS validation[EB/OL].3rd PQRI/FDA Conference on Advancing Product Quality.[2017-03-23].http://pqri.org/wp-content/uploads/2017/02/2-Radulescu.pdf.
[8]LUCK MC.Equivalence of locally-acting drug products[EB/OL].[2017-05-03].https://www.fda.gov/downloads/drugs/newsevents/ucm560383.pdf.
[9]ROBERTS M.Correlation of physicochemical characteristics and in vitro permeation test(IVPT)results for acyclovir and metronidazole topical products[EB/OL].[2017-10-20].https://www.fda.gov/downloads/drugs/newsevents/ucm591896.pdf.
[10]TROTTET L,OWEN H,HOLME P,et al.Areall aciclovir cream formulations bioequivalent[J].Int J Pharm,2005,304(1-2):63-71.
[11]WHO Technical Report Series,No.902,2002,Annex 11.Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource(generic)products[EB/OL].[2002].http://apps.who.int/medicinedocs/documents/s19641en/s19641en.pdf.
[2]FDA.Product-specific guidances for generic drug development.draft guidance on Acyclovir[EB/OL].[2016-12].https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm428195.pdf.
[3]郭涤亮,徐萍蔚,王亚敏.皮肤局部外用仿制药质量等同性评价的一般考虑[J].中国新药杂志,2018,27(18):2116-2120.
[4]EMA.Concept paper on the development of a guideline on quality and equivalence of topical products[EB/OL].[2015-04-22].http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500186088&mid=WC0b01ac058009a3dc.
[5]许鸣镝,牛剑钊,杨东升,等.欧盟仿制药参比制剂检索示例[J].中国新药杂志,2018,27(1):26-30.
[6]许鸣镝,牛剑钊,杨东升,等.欧盟仿制药参比制剂介绍[J].中国新药杂志,2017,26(24):2933-2936.
[7]R?DULESCU F爦,MIRON DS.Physicochemical characterization of Acyclovir topical semisolid dosage forms towards TCS validation[EB/OL].3rd PQRI/FDA Conference on Advancing Product Quality.[2017-03-23].http://pqri.org/wp-content/uploads/2017/02/2-Radulescu.pdf.
[8]LUCK MC.Equivalence of locally-acting drug products[EB/OL].[2017-05-03].https://www.fda.gov/downloads/drugs/newsevents/ucm560383.pdf.
[9]ROBERTS M.Correlation of physicochemical characteristics and in vitro permeation test(IVPT)results for acyclovir and metronidazole topical products[EB/OL].[2017-10-20].https://www.fda.gov/downloads/drugs/newsevents/ucm591896.pdf.
[10]TROTTET L,OWEN H,HOLME P,et al.Areall aciclovir cream formulations bioequivalent[J].Int J Pharm,2005,304(1-2):63-71.
[11]WHO Technical Report Series,No.902,2002,Annex 11.Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource(generic)products[EB/OL].[2002].http://apps.who.int/medicinedocs/documents/s19641en/s19641en.pdf.