Abstract
The creation of drug 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.
Keywords: Nanomedicines, drug product attributes, endotoxin, immunotoxicology, nonbiological complex drugs.
Graphical Abstract
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