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2145 Drug formulation strategies: A vital but nearly invisible component in translational education

机译:2145药物配制策略:转化教育中至关重要但几乎看不见的组成部分

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摘要

OBJECTIVES/SPECIFIC AIMS: To develop a KL2 curriculum on the science and art of drug formulation. METHODS/STUDY POPULATION: Develop training materials for KL2 scholars that outline the art of formulation development. Materials will include syllabi, reading materials, and course work. RESULTS/ANTICIPATED RESULTS: This will enhance the training of KL2 scholars by incorporating formulation development concepts into their human health enhancing research projects. DISCUSSION/SIGNIFICANCE OF IMPACT: For new chemical entities, formulation goals must be realistic and move along in a step-wise manner from the laboratory bench, through toxicology studies, and on to Phase 1 studies. By training scholars in phase-specific formulation goals, their interactions with funding agencies, formulation scientists, and regulators will be more efficient, productive, and successful. For those scholars who are working to improve existing treatments, introducing the concept of formulation improvements that can create new indications, or improve efficacy, safety and patient compliance will open up more possibilities for creative product development.
机译:目标/特定目标:制定有关药物配方科学和艺术的KL2课程。方法/研究人群:为KL2学者编写培训材料,概述配方开发的技术。教材将包括教学大纲,阅读材料和课程作业。结果/预期结果:通过将配方开发概念纳入其人类健康促进研究项目,这将加强KL2学者的培训。讨论/意义:对于新的化学实体,制剂目标必须切合实际,并逐步地从实验室工作台,通过毒理学研究一直到第一阶段研究。通过针对特定阶段的配方目标对学者进行培训,他们与供资机构,配方科学家和监管机构的互动将更加有效,富有成效和成功。对于那些致力于改善现有治疗方法的学者而言,引入可以创造新适应症或改善疗效,安全性和患者依从性的制剂改进概念将为创新产品开发开辟更多可能性。

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