There are several different types of drug delivery interfaces available on the market.Using the right interface for aerosol drug delivery to children is essential for effective inhalation therapy.However,clinicians us...There are several different types of drug delivery interfaces available on the market.Using the right interface for aerosol drug delivery to children is essential for effective inhalation therapy.However,clinicians usually focus on selecting the right drug-device combination and often overlook the importance of interface selection that lead to suboptimal drug delivery and therapeutic response in neonates and pediatrics.Therefore,it is necessary to critically assess each interface and understand its advantage and disadvantages in aerosol drug delivery to this patient population.The purpose of this paper is to provide a critical assessment of drug delivery interfaces used for the treatment of children with pulmonary diseases by emphasizing advantages and problems associated with their use during inhalation therapy.展开更多
目的系统阐述局部作用的鼻用喷雾剂和鼻用气雾剂生物等效性(bioequivalence,BE)评估背景,以及美国、欧盟和中国监管机构对该类复杂药械组合BE评估的基本要求。方法详细解释美国食品药品监督管理局(Food and Drug Administration,FDA)采...目的系统阐述局部作用的鼻用喷雾剂和鼻用气雾剂生物等效性(bioequivalence,BE)评估背景,以及美国、欧盟和中国监管机构对该类复杂药械组合BE评估的基本要求。方法详细解释美国食品药品监督管理局(Food and Drug Administration,FDA)采用的创新性证据加权理念,和该类制剂BE评估的统计学原理、方法和考量。通过FDA颁布的布地奈德吸入混悬液指导原则和丙酸氟替卡松鼻用喷雾剂指导原则草案中的计算方法,通过R语言编程计算双侧和单侧群体生物等效性(population bioequivalence,PBE)计算统计学参数,并提供计算程序的伪代码。介绍了欧盟和中国对于鼻用喷雾剂和鼻用气雾剂相关的指导原则和评审理念。结果与结论局部作用的鼻用喷雾剂/鼻用气雾剂为近年来新药及仿制药开发的热点,本文为该类制剂的研发、质量控制以及仿制制剂BE评价提供有益的思路与参考。展开更多
文摘There are several different types of drug delivery interfaces available on the market.Using the right interface for aerosol drug delivery to children is essential for effective inhalation therapy.However,clinicians usually focus on selecting the right drug-device combination and often overlook the importance of interface selection that lead to suboptimal drug delivery and therapeutic response in neonates and pediatrics.Therefore,it is necessary to critically assess each interface and understand its advantage and disadvantages in aerosol drug delivery to this patient population.The purpose of this paper is to provide a critical assessment of drug delivery interfaces used for the treatment of children with pulmonary diseases by emphasizing advantages and problems associated with their use during inhalation therapy.
文摘目的系统阐述局部作用的鼻用喷雾剂和鼻用气雾剂生物等效性(bioequivalence,BE)评估背景,以及美国、欧盟和中国监管机构对该类复杂药械组合BE评估的基本要求。方法详细解释美国食品药品监督管理局(Food and Drug Administration,FDA)采用的创新性证据加权理念,和该类制剂BE评估的统计学原理、方法和考量。通过FDA颁布的布地奈德吸入混悬液指导原则和丙酸氟替卡松鼻用喷雾剂指导原则草案中的计算方法,通过R语言编程计算双侧和单侧群体生物等效性(population bioequivalence,PBE)计算统计学参数,并提供计算程序的伪代码。介绍了欧盟和中国对于鼻用喷雾剂和鼻用气雾剂相关的指导原则和评审理念。结果与结论局部作用的鼻用喷雾剂/鼻用气雾剂为近年来新药及仿制药开发的热点,本文为该类制剂的研发、质量控制以及仿制制剂BE评价提供有益的思路与参考。
