c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children - A c4c expert group white paper.
c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children - A c4c expert group white paper.
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DOI：
10.1111/bcp.15119
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发表时间：
2022-12
影响因子：
3.4
通讯作者：
中科院分区：
文献类型：
--
作者：
与成人相比，儿童对治疗的反应往往不同。儿科年龄组之间在疗效和安全性方面的药代动力学和药效学也存在差异。儿科药物警戒需要了解儿童的独特方面，例如药物反应、生长和发育、药物不良反应（ADR）的临床表现、如何检测以及人群特异性因素（例如，更频繁地使用标签外/未经许可的药物）。认识到这些挑战，一个专家组已经在conect 4children（c4 c）项目的背景下成立，以支持儿科药物开发。该专家组合作开发了本文所述药品整个生命周期中儿科药物安全性和药物警戒的方法学考虑因素。这些考虑因素包括制定风险管理计划（RMP）儿科章节时需要考虑的实际要点、儿科方案制定中的安全性、安全性数据收集和分析。此外，他们描述了儿童上市后药物警戒的具体细节，例如使用自发报告、电子医疗保健记录、登记和记录链接，以及使用儿科药物流行病学研究进行风险表征。接下来，提供了儿科研究计划（PIP）背景下与药品制剂相关的获益-风险和挑战评估的详细信息。最后，儿科信号检测和评估的实际问题。本文提供了在药品的整个生命周期中，针对RMP、方案制定、安全性数据收集和分析以及PIP进行儿科药物警戒时需要考虑的实际要点。
Children frequently respond differently to therapies compared to adults. Differences also exist between paediatric age groups for pharmacokinetics and pharmacodynamics in both efficacy and safety. Paediatric pharmacovigilance requires an understanding of the unique aspects of children with regard to, for example, drug response, growth and development, clinical presentation of adverse drug reactions (ADRs), how they can be detected and population‐specific factors (e.g., more frequent use of off‐label/unlicensed drugs). In recognition of these challenges, a group of experts has been formed in the context of the conect4children (c4c) project to support paediatric drug development. This expert group collaborated to develop methodological considerations for paediatric drug safety and pharmacovigilance throughout the life‐cycle of medicinal products which are described in this article. These considerations include practical points to consider for the development of the paediatric section of the risk management plan (RMP), safety in paediatric protocol development, safety data collection and analysis. Furthermore, they describe the specific details of post‐marketing pharmacovigilance in children using, for example, spontaneous reports, electronic health care records, registries and record‐linkage, as well as the use of paediatric pharmacoepidemiology studies for risk characterisation. Next the details of the assessment of benefit–risk and challenges related to medicinal product formulation in the context of a Paediatric Investigation Plan (PIP) are presented. Finally, practical issues in paediatric signal detection and evaluation are included. This paper provides practical points to consider for paediatric pharmacovigilance throughout the life‐cycle of medicinal products for RMPs, protocol development, safety data collection and analysis and PIPs.
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DOI：
10.1038/jp.2017.165
发表时间：
2018-03
期刊：
Journal of perinatology : official journal of the California Perinatal Association
影响因子：
--
作者：
Akinmboni TO;Davis NL;Falck AJ;Bearer CF;Mooney SM
通讯作者：
Mooney SM
影响因子：
4.2
作者：
Caster, Ola;Juhlin, Kristina;Watson, Sarah;Noren, G. Niklas
通讯作者：
Noren, G. Niklas
影响因子：
4.2
作者：
Aagaard, Lise;Strandell, Johanna;Hansen, Ebba Holme
通讯作者：
Hansen, Ebba Holme
影响因子：
2.2
作者：
Bridges, Ana J.;Holler, Karen A.
通讯作者：
Holler, Karen A.
影响因子：
5.6
作者：
Budi, Tamas;Toth, Katalin;Monostory, Katalin
通讯作者：
Monostory, Katalin