Pharma-Guidelines-Nanodrug002
Technical Guiding Principles for Nonclinical Pharmacokinetic Research of Nanomedicines (Trial Implementation) (English Version)
- Standard No.
- Pharma-Guidelines-Nanodrug002
- Language
- Chinese, Available in English version
- Release Date
- 2021
- Published By
- National Health Commission of the People's Republic of China
- Scope
- Nanomedicine as mentioned in this guideline refers to nanoscale particles made from raw materials using nanopreparation technology, or nanoscale particles formed by combining raw materials with appropriate carrier materials, and their final products. Pharmaceutical preparations. Compared with ordinary drugs, nanomedicines have scale effects based on nanostructures and can achieve a variety of goals. Nanomedicines are usually divided into three categories: drug nanoparticles, carrier nanomedicines and other nanomedicines. For the scope, characteris ics and classification information of nanomedicines, please refer to the "Technical Guidance Principles for Quality Control Research of Nanomedicines (Trial)". This guiding principle applies to carrier nanomedicines and drug nanoparticles, but does not apply to other types of nanomedicines. The drafting of this guideline is based on the current scientific understanding of nanomedicines. With the progress and experience accumulation of nanomedicine scientific research, the relevant content will be continuously improved and updated in a timely manner.
