Ten Years of the Manufacturing Classification System: A review of literature applications and an extension of the framework to continuous manufacture

IF 2.6 4区医学 Q2 PHARMACOLOGY & PHARMACY

Pharmaceutical Development and Technology Pub Date : 2024-04-15 DOI:10.1080/10837450.2024.2342953

Michael Leane, Kendal Pitt, Gavin Reynolds, Sune Andersen, Brian Carlin, Abina Crean, John Gamble, Michael Gamlen, Bindhu Gururajan, Yaroslav Z. Khimyak, Peter Kleinebudde, Martin Kuentz, Zdravka Misic, Chris Moreton, Stefanie Peter, Stephen Sheehan, Elaine Stone, Anthony Tantuccio, Bernd Van Snick

引用次数: 0

Abstract

The MCS initiative was first introduced in 2013. Since then, two MCS papers have been published: the first proposing a structured approach to consider the impact of drug substance physical properti...

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制造分类系统十年：文献应用回顾及将框架扩展至连续制造

MCS倡议于2013年首次提出。从那时起，已经发布了两份监控监文件：第一份文件提出了一种结构化方法，以考虑药物物质对物理特性的影响；第二份文件提出了一种结构化方法，以考虑药物物质对物理特性的影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmaceutical Development and Technology 医学-药学

CiteScore

5.90

自引率

2.90%

发文量

审稿时长

1 months

期刊介绍： Pharmaceutical Development & Technology publishes research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems, emphasizing practical solutions and applications to theoretical and research-based problems. The journal aims to publish significant, innovative and original research to advance the frontiers of pharmaceutical development and technology. Through original articles, reviews (where prior discussion with the EIC is encouraged), short reports, book reviews and technical notes, Pharmaceutical Development & Technology covers aspects such as: -Preformulation and pharmaceutical formulation studies -Pharmaceutical materials selection and characterization -Pharmaceutical process development, engineering, scale-up and industrialisation, and process validation -QbD in the form a risk assessment and DoE driven approaches -Design of dosage forms and drug delivery systems -Emerging pharmaceutical formulation and drug delivery technologies with a focus on personalised therapies -Drug delivery systems research and quality improvement -Pharmaceutical regulatory affairs This journal will not consider for publication manuscripts focusing purely on clinical evaluations, botanicals, or animal models.