在泰国制药行业开发持续释放增量修饰药物的财务可行性:混合方法研究研究
Manthana Laichapis1, Rungpetch Sakulbumrungsil1, Khunjira Udomaksorn2
1Department of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences, Chulalongkorn University, 254 Phayathai Road, Pathum Wan, Bangkok, 10500, Thailand, 66 8-860-318-88.
JMIRx med
|July 1, 2025
概括
在泰国开发持续释放增量修饰药物 (IMD) 需要大量的投资和时间. 财务可行性取决于战略研发,高效的流程和支持创新的政策.
科学领域:
- 制药行业分析分析 制药行业分析
- 药物开发经济学 药物开发经济学
- 医疗保健创新战略 医疗保健创新战略
背景情况:
- 泰国制药行业的目标是通过增量修改药物 (IMD) 实现创新和自力更生.
- 专注于持续释放剂型作为IMD发展的关键领域.
- 开发这些IMD的财务可行性尚不清楚.
研究的目的:
- 评估在泰国开发持续释放IMD的财务可行性.
- 分析战略决策的成本,时间表和投资需求.
- 为泰国制药行业的创新目标提供见解.
主要方法:
- 采用混合方法方法,整合文献评论,专家采访和财务建模.
- 评估了两种发展场景:仅进行I期开发,以及完整的临床试验 (I-III期).
- 利用灵敏度分析来检查关键变量对财务结果的影响.
主要成果:
- 持续释放的IMD开发跨越7年 (仅I阶段) 耗资146至309万美元,或11年 (全试验) 耗资1860至2023万美元.
- 过程验证批量占据了第一阶段的成本 (60%),而临床试验占据了全部试验成本的70%.
- 五年回报期所需的年收入范围从0.20-1.80M美元 (仅I阶段) 到3.01-27.11M美元 (全试验).
结论:
- 在泰国开发持续释放性IMD带来了巨大的成本和时间挑战,但却提供了比新化学实体更低风险的途径.
- 提高财务可行性需要战略投资,优化研发和支持政府政策.
- 成功开发IMD支持泰国国家制药创新和自给自足的目标.
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