邀请函invitation - us pharmacopeial convention.pdf

邀请函 Invitation 美国药典委员会中华区总部诚挚地邀请您参加将在上海举办的药典培训课程。 USP-China sincerely invites you to attend the following USP Pharmacopeial Education course. 生物活性检测方法的设计、开发和验证 Bioassay Design, Development, and Validation 时间/地点Time/Location: 2017 年4 月17 日 Apr. 17, 2017 上海 Shanghai, China 课程简介 Course Description: 众所周知，生物活性检测法 (Bioassay) 是生物学、医学、特别是毒理学的重要内容和基础，在新药研究等过程 中起了关键性的作用。 作为美国药典委员会(USP)经典生物制品和生物技术类药典培训课程，本课程由USP 总部专家来华亲临授课。课 程在研究生物活性检测法各因子的变异性在独立于测试组分的生物活性水平下对效价评定的影响、为降低这些潜在 干扰可采用的相对于标准来源的效价衡量方法的基础上，将全面介绍生物活性检测方法的设计、开发和验证中需要 考虑的基本要素 ，包括美国药典的相关通则、术语、相对效价、生物活性检测周期、重要工具与前提条件、良好操 作规范等内容，并对生物活性检测方法的设计、开发、耐用性、验证和后验证等主题进行详细讨论。通过学习，您 将了解如何有效的进行生物活性检测方法的设计、优化和解决问题，同时建立活性检测的定量、高通量的实行和多 步连续活性检测实行的可能性的考量。 This one-day bioassay course will focus on the essential factors to be considered in the design, development, and validation of bioassays. The course introduces related USP general chapters, terminology, relative potency, bioassay life cycle, important tools and prerequisites, and best practices, followed by a detailed discussion on the topics of design and development, robustness, validation, and post-validation. The course ends with an example of a USP pharmacopeial bioassay. Course will examine how variability in bioassay factors could influence the potency assessment independent of the level of biological activity of the tested ingredient. In order to mitigate these potential interferences, a measure of potency relative to a standard source could be applied. Therefore, it becomes important to effectively perform: the assay design, optimization, and trouble shooting. And one also needs to consider aspects of assay qualification and execution with rapid throughput and the potential for multiple sequential assay implementations. 参加对象 Who Should Attend: 课程专为从事生物活性检测验证工