Abstract：
UNASSIGNED: Intramuscular (IM) injections deliver a plethora of drugs. The majority of IM-related literature details dissolution and/or pharmacokinetic (PK) studies, using methods with limited assessments of post-injection events that can impact drug fate, and absorption parameters. Food and Drug Association guidelines no longer require preclinical in vivo modeling in the U.S.A. Preclinical animal models fail to correlate with clinical outcomes, highlighting the need to study, and understand, IM drug fate in vitro using bespoke models emulating human IM sites. Post-IM injection events, i.e. underlying processes that influence PK outcomes, remain unacknowledged, complicating the application of in vitro methods in preclinical drug development. Understanding such events could guide approaches to predict and modulate IM drug fate in humans.
UNASSIGNED: This article reviews challenges in biorelevant IM site modeling (i.e. modeling drug fate outcomes), the value of technologies available for developing IM injectables, methods for studying drug fate, and technologies for training in performing IM administrations. PubMed, Web-of-Science, and Lens databases provided papers published between 2014 and 2024.
UNASSIGNED: IM drug research is expanding what injectable therapeutics can achieve. However, post-injection events that influence PK outcomes remain poorly understood. Until addressed, advances in IM drug development will not realize their full potential.
UNASSIGNED: This article reviews challenges in biorelevant IM site modeling (i.e. modeling drug fate outcomes), the value of technologies available for developing IM injectables, methods for studying drug fate, and technologies for training in performing IM administrations. PubMed, Web-of-Science, and Lens databases provided papers published between 2014 and 2024.
UNASSIGNED: IM drug research is expanding what injectable therapeutics can achieve. However, post-injection events that influence PK outcomes remain poorly understood. Until addressed, advances in IM drug development will not realize their full potential.
摘要：
■肌内（IM）注射可提供过多的药物。大多数IM相关文献详述了溶出度和/或药代动力学(PK)研究，使用对可能影响药物命运的注射后事件进行有限评估的方法，和吸收参数。美国食品和药物协会指南不再要求临床前体内建模，临床前动物模型不能与临床结果相关。强调学习的必要性，并且理解,使用模拟人IM位点的定制模型在体外的IM药物命运。后IM注入事件，即影响PK结果的潜在过程，仍然不被承认，使体外方法在临床前药物开发中的应用复杂化。了解这些事件可以指导预测和调节人IM药物命运的方法。
■本文回顾了生物相关IM位点建模（即建模药物命运结果）的挑战，可用于开发IM注射剂的技术的价值，研究药物命运的方法，以及执行IM管理的培训技术。PubMed,Web-of-Science,和Lens数据库提供了2014年至2024年之间发表的论文。
■IM药物研究正在扩大可注射疗法可以实现的目标。然而,对影响PK结果的注射后事件了解甚少。在解决之前，IM药物开发的进展将不会充分发挥其潜力。
■本文回顾了生物相关IM位点建模（即建模药物命运结果）的挑战，可用于开发IM注射剂的技术的价值，研究药物命运的方法，以及执行IM管理的培训技术。PubMed,Web-of-Science,和Lens数据库提供了2014年至2024年之间发表的论文。
■IM药物研究正在扩大可注射疗法可以实现的目标。然而,对影响PK结果的注射后事件了解甚少。在解决之前，IM药物开发的进展将不会充分发挥其潜力。
