口服吸入药物产品的扩大规模和批准后的变化:科学和监管方面的考虑
Gur Jai Pal Singh1, S Prasad Peri2
1BBSG Pharm Associates, Corona, California, USA.
Journal of aerosol medicine and pulmonary drug delivery
|December 9, 2024
概括
本文讨论了口服吸入药物产品 (OIDP) 的扩大和后审批变更 (SUPAC) 监管准则的必要性. 它讨论了科学和监管方面的考虑,以制定这些关键的OIDP的SUPAC指南.
科学领域:
- 制药科学 制药科学
- 监管科学 监管科学
- 药物输送系统 药物输送系统
背景情况:
- 经批准的药物产品经常经历变化 (例如,批量大小,制造工厂),需要进行监管评估.
- 美国食品和药物管理局现有的扩大和后审批变更 (SUPAC) 指南涵盖固体口服和半固体配方,但不包括口服吸入药物 (OIDP).
- OIDP是复杂的药物-设备组合产品,需要对批准后的变化做出具体考虑.
研究的目的:
- 为制定口服吸入药物产品 (OIDP) 的SUPAC指南作出重要贡献.
- 讨论在OIDP中解决SUPAC的科学方面和监管基础.
- 概述评估变化对OIDP性能,安全性和有效性的影响的考虑因素.
主要方法:
- 对其他剂型的现有FDA SUPAC指南的审查.
- 讨论OIDPs作为药物设备组合所带来的独特挑战.
- 对影响OIDP批准后变化的科学和监管因素的分析.
主要成果:
- 确定了OIDP中SUPAC目前的监管指南中的一个漏洞.
- 强调需要考虑OIDPs药物成分,配方和设备组件的变化.
- 强调了多个变化对OIDP安全性和有效性的复合效应.
结论:
- 需要OIDP SUPAC的正式监管准则,这篇文章提供了基础讨论.
- 开发OIDP SUPAC指南需要来自行业和监管机构的多学科投入.
- 当局的个案评估将确定OIDP SUPAC的适用准则.
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