在国际制药监管机构计划中,生物等效研究设计建议立即释放的固体口服剂型参与监管机构和组织:差异和共同点
Eduardo Agostinho Freitas Fernandes1, Joy van Oudtshoorn2, Andrew Tam3
1Agência Nacional de Vigilância Sanitária, Brasília, Brazil.
概括
生物等价性 (BE) 研究确保仿制药的性能与原始药物一样. 关于立即释放口服剂型的建议侧重于健康受试者的单剂量交叉研究,并对复杂药物有所变化.
科学领域:
- 制药科学 制药科学
- 药品监管事务 药品监管事务
- 药理动力学 药理动力学
背景情况:
- 对仿制药的批准而言,生物等价性 (BE) 研究至关重要,它证明了对创新产品的治疗等价性.
- 国际制药监管机构计划 (IPRP) 仿制药生物等价性工作组 (BEWGG) 提供了对BE研究进行的建议.
- 立即释放的固体口服剂型是BE评估的主要焦点.
研究的目的:
- 概述BEWGG成员关于对立即释放固体口服剂型进行和接受BE研究的建议.
- 在国际监管机构中确定BE研究要求的共同实践和分歧领域.
- 为全球BE研究指南的协调过程提供信息.
主要方法:
- 一项调查分发给BEWGG成员,以收集他们对BE研究建议和要求的数据.
- 调查的主要领域包括研究对象,设计,样本大小,剂量,条件,分析物测量,产品强度,药物含量,内源物质,接受标准和设计方面.
- 结果和讨论与ICH M13专家工作组 (EWG) 分享.
主要成果:
- 在BEWGG成员之间存在共识,他们更喜欢在健康受试者身上进行单剂量,交叉的BE研究,至少有12名参与者.
- 使用母药数据是评估生物等价性的首选方法.
- 研究设计 (例如,禁食与食) 和复杂药物的接受标准存在差异,包括高度可变或狭窄的治疗指数药物.
结论:
- 对于立即释放的固体口服剂型的BE研究的标准化方法在很大程度上已经达成一致.
- 根据BEWGG建议,监管协调工作正在取得进展,这可以从ICH M13A指南的制定中得到证实.
- 解决药理动力学和药理动力学方面的复杂性对于完善BE研究设计和接受标准至关重要.
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