Safety Considerations of Cancer Nanomedicine – A key step towards translation
| Autor: | Ivanna Tang, Huan Meng, Xiangsheng Liu, Zev A. Wainberg |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Computer science
Combined use Antineoplastic Agents 02 engineering and technology 010402 general chemistry Toxicology 01 natural sciences Article Biomaterials Neoplasms Humans General Materials Science In patient Strategic planning Rapid expansion General Chemistry 021001 nanoscience & nanotechnology 0104 chemical sciences Nanostructures Nanomedicine Risk analysis (engineering) Key (cryptography) Drug and Narcotic Control 0210 nano-technology Biotechnology |
| Zdroj: | Small |
| Popis: | The rate of translational effort of nanomedicine requires strategic planning of nanosafety research in order to enable clinical trials and safe use of nanomedicine in patients. In this communication, we will discuss the experiences that have emerged based on the safety data of classic liposomal formulations in the space of oncology, as well as describing the new challenges that need to be addressed according to the rapid expansion of nanomedicine platform beyond liposomes. It is valuable to consider the combined use of predictive toxicological assessment supported by deliberate investigation on aspects such as ADME (absorption, distribution, metabolism, and excretion) and toxicokinetic profiles, the risk that may be introduced during nano manufacture, unique nanomaterial properties, non-obvious nanosafety endpoints, etc. These efforts will allow the generation of IND (investigational new drug)-enabling safety data that can be incorporated into a rational infrastructure for regulatory decision-making. Since the safety assessment relates to nanomaterials, the investigation should cover the important physicochemical properties of the material that may lead to hazard when nanomedicine product is utilized in humans. |
| Databáze: | OpenAIRE |
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