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Thinking about Target Product Attributes in Basic Nanomedicine Research and Positive Impacts on the Design of Nano-Immunotoxicology Studies

机译:基础纳米医学研究中目标产品属性的思考及其对纳米免疫毒理学研究设计的积极影响

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摘要

The creation of drag product attributes, sometimes known as target product specifications, is a common practice in the early research and development phase of conventional medicines and biopharmaceuticals, but not often applied to basic nanomedicine research. Encompassing a detailed concept of the dosage form, route of administration safety, efficacy, identity, strength, performance, quality of the drug product at release and during storage through the end of its shelf-life, target product attributes guide the development process, ensuring a high quality and consistency of the medicine. In light of the more rigorous requirements for test material quality in immunotoxicology studies, such as nanomaterial sterility and low endotoxin content, the concept of creating conceptual target product attribute lists for basic researchers involved in nanomedicine design and development is discussed. Relevant examples of target product profiles are provided for comparison and nanomaterial-specific considerations are reviewed.
机译:在传统药物和生物药物的早期研究和开发阶段,拖动产品属性的创建(有时称为目标产品规格)是一种常见做法,但并不经常应用于基础纳米医学研究。涵盖剂型的详细概念,给药的安全性,功效,特性,强度,性能,质量,包括在产品释放时以及在产品的保质期结束时的质量,目标产品属性可指导开发过程,确保高质量和一致性的药物。鉴于免疫毒理学研究对测试材料质量提出了更严格的要求,例如纳米材料的无菌性和低内毒素含量,讨论了为参与纳米医学设计和开发的基础研究人员创建概念性目标产品属性列表的概念。提供了目标产品概况的相关示例以进行比较,并审查了纳米材料特定的注意事项。

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