White paper: Understanding, informing and defining the regulatory science of microneedle-based dosage forms that are applied to the skin

剂型 风险分析(工程) 关键质量属性 活性成分 质量(理念) 生物制药 计算机科学 管理科学 医学 设计质量 过程管理 新产品开发 药理学 业务 生物技术 工程类 营销 认识论 哲学 生物
作者
Maria Dul,Mohammed Alali,Mahmoud Ameri,Matthew Douglas Burke,Benjamin Paul Creelman,Lisa Dick,Ryan F. Donnelly,Michael N. Eakins,Collrane Frivold,Angus H. Forster,Philippe‐Alexandre Gilbert,Stefan Henke,Sébastien Henry,Desmond Hunt,Hayley Lewis,Jessica Joyce Mistilis,Jung‐Hwan Park,Mark R. Prausnitz,David Kenneth Robinson,Carmen Amelia Rodriguez Hernandez
出处
期刊:Journal of Controlled Release [Elsevier]
卷期号:378: 402-415
标识
DOI:10.1016/j.jconrel.2024.11.056
摘要

The COVID-19 pandemic has accelerated pre-clinical and clinical development of microneedle-based drug delivery technology. However the regulatory science of this emerging dosage form is immature and explicit regulatory guidance is limited. A group of international stakeholders has formed to identify and address key issues for the regulatory science of future products that combine a microneedle device and active pharmaceutical ingredient (in solid or semi-solid state) in a single entity that is designed for application to the skin. Guided by the principles of Quality by Design (QbD) and informed by consultation with wider stakeholders, this 'White Paper' describes fundamental elements of the work in an effort to harmonise understanding, stimulate discussion and guide innovation. The paper discusses classification of the dosage form (combination/medicinal product), the regulatory nomenclature that is likely to be adopted and the technical vocabulary that best describes its form and function. More than twenty potential critical quality attributes (CQAs) are identified for the dosage form, and a prioritisation exercise identifies those CQAs that are most pertinent to the dosage form and that will likely require bespoke test methods (delivered dose, puncture performance) or major adaptions to established compendial test methods (dissolution). Hopefully the work will provide a platform for the development of dosage form specific guidance (from regulatory authorities and/or international pharmacopoeias), that expedites clinical translation of safe and effective microneedle-based products.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
1秒前
搞科研的蜡笔小新完成签到,获得积分20
2秒前
一一一完成签到 ,获得积分10
3秒前
3秒前
3秒前
平常的凡白完成签到 ,获得积分10
3秒前
RerrentLinden完成签到,获得积分10
6秒前
Nito发布了新的文献求助50
7秒前
libobobo完成签到,获得积分10
7秒前
古德day发布了新的文献求助10
7秒前
Andy发布了新的文献求助10
8秒前
Akim应助senlin采纳,获得10
8秒前
cyskdsn完成签到 ,获得积分10
8秒前
zxj发布了新的文献求助10
8秒前
坚定思光发布了新的文献求助10
8秒前
我是老大应助XYN1采纳,获得10
9秒前
科研通AI5应助聆雨霖铃采纳,获得10
10秒前
11秒前
11秒前
迟大猫应助冯冯采纳,获得200
12秒前
13秒前
13秒前
he发布了新的文献求助10
13秒前
迟大猫应助坚定思光采纳,获得10
15秒前
阿珩发布了新的文献求助10
17秒前
17秒前
不想学习发布了新的文献求助10
18秒前
18秒前
18秒前
guojingjing发布了新的文献求助10
19秒前
soybean完成签到,获得积分10
20秒前
20秒前
21秒前
斯文败类应助科研通管家采纳,获得10
21秒前
科研通AI5应助科研通管家采纳,获得10
21秒前
完美世界应助科研通管家采纳,获得10
21秒前
21秒前
21秒前
甜美芷烟完成签到,获得积分10
21秒前
华仔应助科研通管家采纳,获得10
21秒前
高分求助中
Continuum Thermodynamics and Material Modelling 3000
Production Logging: Theoretical and Interpretive Elements 2700
Les Mantodea de Guyane Insecta, Polyneoptera 1000
Structural Load Modelling and Combination for Performance and Safety Evaluation 1000
Conference Record, IAS Annual Meeting 1977 820
電気学会論文誌D(産業応用部門誌), 141 巻, 11 号 510
Typology of Conditional Constructions 500
热门求助领域 (近24小时)
化学 材料科学 生物 医学 工程类 有机化学 生物化学 物理 纳米技术 计算机科学 内科学 化学工程 复合材料 基因 遗传学 物理化学 催化作用 量子力学 光电子学 冶金
热门帖子
关注 科研通微信公众号,转发送积分 3570690
求助须知:如何正确求助?哪些是违规求助? 3141392
关于积分的说明 9442819
捐赠科研通 2842740
什么是DOI,文献DOI怎么找? 1562418
邀请新用户注册赠送积分活动 731079
科研通“疑难数据库(出版商)”最低求助积分说明 718290