在多个提交中使用相同的模型或建模策略:专注于复杂的药物产品
Ross L Walenga1, Andrew H Babiskin2, Sid Bhoopathy3
1Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA. Ross.Walenga@fda.hhs.gov.
建模和模拟越来越多地用于复杂的仿制药开发和批准. 一场研讨会探讨了模型重复使用框架,并解决了各种药物产品类别的挑战.
科学领域:
- 药理动力学和药理动力学
- 计算科学 计算科学
- 药物开发 药物开发
背景情况:
- 美国在复杂的仿制药产品开发和批准方面越来越多地采用建模和模拟 (M&S).
- 引入机械建模和模型整合证据 (MIE) 作为监管提交的关键组成部分.
- 需要标准化的方法来支持日益复杂的仿制药产品.
结论:
- 强调FDA与仿制药行业之间需要持续沟通.
- 通过会议和FDA发布的指南,呼吁促进MS的成熟.
- 研讨会提供了对复杂仿制药的M&S当前状态的见解,以及跨产品模型应用的机会.
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