经口吸入制剂仿制药生物等效性评价过程中质量管理关键点探讨

Discussion on key points of quality management in the process of bioequivalence evaluation of generic drugs for orally inhaled drug products

经口吸入制剂通过搭载特殊的给药装置将药物递送至呼吸道和(或)肺部以发挥局部或全身作用,被用于治疗慢性呼吸系统疾病。目前,我国经口吸入制剂的使用仍以进口为主,患者用药成本较高,开展仿制药一致性评价将有助于降低患者经济负担。由于经口吸入制剂自身设计的特殊性和给药过程中的复杂性,在进行仿制药生物等效性评价过程中的准备阶段、进行阶段、结束阶段等关键环节把控好坏会直接影响临床试验质量,从而影响仿制药一致性评价结果。徐州医科大学附属医院是大型省属三级甲等综合医院,在经口吸入制剂仿制药生物等效性评价过程中积累了丰富经验。医院结合多年来开展经口吸入制剂仿制药生物等效性评价过程中的经验,对临床试验过程中质量管理的关键环节进行探讨,从而确保临床试验质量,有助于提升经口吸入制剂仿制药一致性评价能力,不仅降低患者用药成本,而且有助于提升国内经口吸入制剂仿制药行业整体水平。

Orally inhaled drug products are used to treat chronic respiratory diseases by carrying a special drug delivery device to deliver drugs to the respiratory tract and/or lungs to exert local or systemic effects.At present,the use of orally inhaled drug products in our country is still mainly imported,and the cost of medication for patients is relatively high.Bioequivalence evaluation of generic drugs will help to reduce patients'economic burden.Due to the particularity of the design of orally inhaled drug products preparations and the complexity of the administration process,such as the preparation stage,the progress stage,and the end stage during the bioequivalence evaluation of generic drugs will directly affect the quality of clinical trials,thereby affecting the results of generic drug consistency evaluation.Affiliated Hospital of Xuzhou Medical University is a large provincial tertiary grade A general hospital,which had accumulated rich experience in the process of bioequivalence evaluation of generic drugs for orally inhaled drug products.Based on years of experience in the process of bioequivalence evaluation of generic drugs for orally inhaled drug products,the hospital discussed the key aspects of quality management during clinical trials,so as to ensure the quality of clinical trials and help improve the ability of generic drug consistency evaluation,not only reduces the cost of medication for patients,but also helps to improve the overall level of the domestic generic drug industry for orally inhaled drug products.