Eli Lilly and Company, Indianapolis, Indiana, USA.
AAPS PharmSciTech. 2011 Jun;12(2):782-94. doi: 10.1208/s12249-011-9634-x. Epub 2011 Jun 18.
In 2003, the FIP Dissolution Working group published a position paper on dissolution/drug release testing for special/novel dosage forms that represented the scientific opinions of many experts in the field at that time (1). The position paper has supported activities, programs, and decisions in the scientific, technical, and regulatory community. Due to the rapid evolution of new practices and techniques for testing, the FIP Special Interest Group (SIG) on Dissolution/Drug Release decided to revise the previous paper and added proposals for further harmonization of release testing practices for different pharmaceutical dosage forms. This article represents the current updates to the previously published paper. This revision has been aligned to coincide with the USP taxonomy including route of administration, intended site of drug release, and dosage form. The revised paper includes information from current literature, expert discussions, and presentations from recent workshops (2,3). The authors acknowledge and expect further updates to be made as additional progress is made in the relevant areas. Thus, comments and additional contributions are welcome and may be considered for the next revision of the position paper.
2003 年，FIP 解散工作组发布了一份关于特殊/新型制剂溶出/药物释放测试的立场文件，该文件代表了当时该领域许多专家的科学意见(1)。该立场文件支持了科学界、技术界和监管界的活动、计划和决策。由于测试新实践和技术的快速发展，FIP 溶出/药物释放特别兴趣小组(SIG)决定修订以前的文件，并提出了进一步协调不同药物制剂释放测试实践的建议。本文代表了先前发表的论文的最新更新。此次修订与 USP 分类法（包括给药途径、预期药物释放部位和剂型）保持一致。修订后的文件包含了来自当前文献、专家讨论和最近研讨会的信息(2,3)。作者承认并期望随着相关领域取得进一步进展，将进行进一步更新。因此，欢迎提出意见和更多建议，并可考虑在下一次修订该立场文件时采纳。
