在儿科中对生物仿制收养的考虑:一个范围审查
Elaine Lau1,2,3, Alicia Koo1, Han Byul Kang1
1Department of Pharmacy, Hospital for Sick Children, 555 University Ave, Toronto, ON, Canada, M5G 1X8.
Pharmaceutical medicine
|December 1, 2025
概括
有限的临床证据阻碍了儿童对生物类似药物的吸收. 需要更多的儿科研究和药物监测,以建立信心,并指导医疗机构在为儿科患者采用生物类似药时.
科学领域:
- 药理学和治疗学 药理学和治疗学
- 医疗保健服务研究 医疗服务研究
- 儿科医学 儿科医学
背景情况:
- 由于临床证据有限和安全性/有效性不确定性,儿科生物类似药的采用落后于成年人.
- 生物制剂的专利到期为生物类似药市场的扩张创造了机会.
- 本次审查解决了对证据的需求,以告知儿科医疗机构关于生物类似的决策.
研究的目的:
- 确定影响儿科卫生保健机构采用生物类似药物的主题.
- 为儿科机构关于生物类似药的使用的决策过程提供信息.
- 为儿童生物类似药物采用制定政策框架.
主要方法:
- 从创立到2024年9月20日的学术和灰色文学范围审查.
- 搜索包括OVID Medline,Embase,国际制药摘要以及监管/HTA机构网站.
- 包括专注于儿科生物类似药的使用和机构决策的研究;不包括非英语的,专注于行业的或仅针对成年人的研究.
主要成果:
- 包括35篇文章 (26篇为儿科专用).
- 14个主题出现,分为实质性 (证据,成本,安全性,剂量形式) 和程序性 (批准,可互换性,教育,监测) 原则.
- 主题为儿科生物类似药采用政策框架提供了信息.
结论:
- 在儿科生物类似药的采用中存在一个重要的卫生系统差距.
- 行业需要进行强大的儿科疗效和安全性市场前研究.
- 加强药物监督和患者登记册对于产生真实世界的证据和建立信任至关重要.
更多相关视频
相关概念视频
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
219
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
219
01:28Drug Products: Biologics, Biosimilars and Interchangeables
208
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
208
01:24Pharmacokinetics in Pediatric Patients: Drug Metabolism
165
In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
165
01:26Pharmacokinetics in Pediatric Patients: Drug Excretion
188
In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
188
01:17Pharmacokinetics in Pediatric Patients: Drug Distribution
231
Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
231
01:16Bioequivalence: Overview
1.6K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.6K