研讨会报告:药品体外性能测试进展USP研讨会

IF 1 4区医学 Q4 PHARMACOLOGY & PHARMACY

Dissolution Technologies Pub Date : 2020-05-01 DOI:10.14227/dt270220p52

Andre Hermans, P. Dorożyński, F. Muzzio, Hanlin Li, Sarah Nielsen, Shirlynn Chen, C. Reppas, S. Klein, Sanjaykumar Patel, M. Wacker, K. Thakker, Katharina Pruessmann, Anne Seidlitz, T. Ghosh, Yang Yang, Daniel R Willett, G. Hochhaus, J. Tay, C. Liew, P. Heng, Changquan Calvin Sun, John C. Kraemer, Margareth R. C. Marques

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引用次数: 3

摘要

2019年12月，美国药典组织了一次为期两天的研讨会，探索评估药物体外性能的新方法。来自世界各地的专家介绍了可用于评估和模拟不同药物剂型体外性能的工艺、技术和系统。以下是大多数专题介绍的摘要以及随后讨论的要点。免责声明：本文反映了作者的观点，不应被解释为代表美国食品和药物管理局的观点或政策。

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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Workshop Report: USP Workshop on Advancements in In Vitro Performance Testing of Drug Products

In December 2019, The United States Pharmacopeia (USP) organized a 2-day workshop to explore new approaches to assess in vitro performance of drug products. Experts from around the globe presented processes, techniques, systems that can be used to evaluate and model in vitro performance of different pharmaceutical dosage forms. The following is a summary of most of the presentations and the highlights of the discussions that ensued. Disclaimer: This article reflects the views of the authors and should not be construed as representing the views or policies of the United States Food and Drug Administration.

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来源期刊

Dissolution Technologies 医学-药学

CiteScore

1.20

自引率

33.30%

发文量

审稿时长

3 months

期刊介绍： Dissolution Technologies is a peer reviewed quarterly publication reporting ongoing, useful information on dissolution testing of pharmaceuticals. It provides an international forum for dissolution analysts to receive and exchange information on various dissolution topics. Dissolution Technologies welcomes submissions related to dissolution, in vitro release, and disintegration testing. These topics should be the major focus of the article. Do not submit articles where the focus is formulation development with dissolution testing as one of many tests.