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泰国的国内制药行业对持续释放剂量形式的增量修改药物的可行性研究
Charkkrit Hongthong1, Rungpetch Sakulbumrungsil2, Khunjira Udomaksorn3
1Faculty of Pharmaceutical Sciences, Khon Kaen University, Nai Mueang, Khon Kaen, 40002, Thailand.
F1000Research
|November 8, 2024
概括
增量修改药物 (IMDs) 在提高药物有效性和合规性方面表现有前途. 虽然在大多数方面都是可行的,但药物注册的监管障碍仍然是IMD发展的挑战.
科学领域:
- 制药科学 制药科学
- 药物开发 药物开发
- 配方科学科学 配方科学
背景情况:
- 增量修改药物 (IMD) 提供了提高药物疗效和患者服药的潜力.
- IMDs提供了一个较低的研发成本替代新化学实体.
- 专注于IMD可以刺激国内制药业的增长.
研究的目的:
- 调查开发增量修改药物的全面可行性.
- 评估IMD发展的需求,市场,科学,技术和监管方面.
- 确定国内制药行业在IMD创新的关键挑战和机遇.
主要方法:
- 采用混合方法方法,将文献综述与在线深入采访相结合.
- 用专题分析分析了定性数据.
- 在五个关键领域评估可行性:需求,市场,科学,技术和监管.
主要成果:
- 医生偏好和行业参与有利于持续释放 (SR) 配方.
- 持续释放 (SR) 市场的复合年增长率为3.97%,表明市场的可行性.
- 科学和技术可行性得到证实,具有高技术准备水平和SR药物的成熟制造技术.
结论:
- 持续释放 (SR) 配方证明了在多个领域逐步修改药物 (IMD) 开发的强大可行性.
- IMD发展的主要障碍在于复杂且目前未经证实的药物注册流程.
- 解决监管途径对于释放IMD的全部潜力至关重要.
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