中国新药杂志

吸入剂生物等效性评价方法介绍与比较

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周沁蕾 ¹^,² , 管宴萍 ³ , 刘晓琳 ¹^,² , 黄民 ¹^,² , 钟国平 ¹^,²

中国新药杂志 | 新药述评与论坛 2021,30(3): 197-204

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中国新药杂志 |新药述评与论坛 2021 , 30 (3) : 197 -204

吸入剂生物等效性评价方法介绍与比较

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周沁蕾¹^,², 管宴萍³, 刘晓琳¹^,², 黄民¹^,², 钟国平¹^,²

作者信息

¹中山大学药学院临床药理研究所数据管理中心，广州　510080

²广东省仿制药一致性评价工程技术研究中心，广州　510080

³中山大学孙逸仙纪念医院药学部，广州　510080

通讯作者:

钟国平，男，副教授，硕士生导师，研究方向：临床药理学及药动学相关研究。联系电话：（020）87335429-113，E-mail：zhonggp@mail.sysu.edu.cn。

作者简介:

周沁蕾，女，硕士研究生，研究方向：临床药理学及药动学相关研究。E-mail：valeryjoey@163.com。

Introduction and comparison of guidelines for bioequivalence evaluation of inhalants

Qin-lei ZHOU¹^,², Yan-ping GUAN³, Xiao-lin LIU¹^,², Min HUANG¹^,², Guo-ping ZHONG¹^,²

Affiliations

¹Data Management Center of Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou 510080, China

²Guangdong Engineering Technology Research Center of Quality Consistency Evaluation for Generic Drugs, Guangzhou 510080, China

³Department of Pharmacy, Sun Yat-Sen Memorial Hospital, Guangzhou 510080, China

出版时间: 2021-02-15

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摘要

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吸入剂相较于普通制剂在剂型、装置及作用方式等方面有其特殊性，吸入剂生物等效性评价若按照普通制剂的评价方法进行，可能导致所得结果的准确度降低，故吸入剂的生物等效性评价具有挑战性。目前，随着市场需求的不断增加，国内对于吸入制剂的研究也呈现上升趋势，但国内尚未正式出台吸入剂生物等效性评价的相关指南，这给相关研究带来一定局限。本文主要通过对美国、欧洲以及加拿大药品管理机构关于吸入制剂生物等效性评价的指南及修订稿进行介绍，并与我国国家药品监督管理局药品审评中心于2019年8月发布的关于公开征求《经口吸入制剂仿制药药学和人体生物等效性研究指导原则》征求意见稿进行比较的基础上，结合具体案例进行分析，以期为国内相关吸入制剂生物等效性研究提供科学参考。

关键词

吸入剂 / 生物等效性 / 指南 / 评价

Abstract

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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.

Key words

inhalant / bioequivalence / guideline / evaluation

引用本文

周沁蕾, 管宴萍, 刘晓琳, 黄民, 钟国平. 吸入剂生物等效性评价方法介绍与比较. 中国新药杂志, 2021 , 30 (3) : 197 -204 .

Qin-lei ZHOU, Yan-ping GUAN, Xiao-lin LIU, Min HUANG, Guo-ping ZHONG. Introduction and comparison of guidelines for bioequivalence evaluation of inhalants[J]. Chinese Journal of New Drugs, 2021 , 30 (3) : 197 -204 .

基金

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广东省科技发展专项基金资助项目(2016A040403047)

参考文献

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2021年第30卷第3期

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首发时间：2026-10-29
出版时间：2021-02-15

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录用日期：2020-03-20

基金

广东省科技发展专项基金资助项目(2016A040403047)

作者信息

¹中山大学药学院临床药理研究所数据管理中心，广州　510080

²广东省仿制药一致性评价工程技术研究中心，广州　510080

³中山大学孙逸仙纪念医院药学部，广州　510080

通讯作者:

钟国平，男，副教授，硕士生导师，研究方向：临床药理学及药动学相关研究。联系电话：（020）87335429-113，E-mail：zhonggp@mail.sysu.edu.cn。

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2种不同金属材料的力学参数

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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