Pharmaceutical process omics and its applications and prospects in drug quality control.
10.19540/j.cnki.cjcmm.20250428.301
- Author:
Yu-Ting LU
1
;
Jia-Yu YANG
1
;
Ying-Ting SHI
1
;
Xin-Yuan XIE
1
;
Jian-Yang PAN
1
;
Hai-Bin QU
1
Author Information
1. Pharmaceutical Informatics Institute, College of Pharmaceutical Sciences, Zhejiang University Hangzhou 310058, China.
- Publication Type:English Abstract
- Keywords:
analytical techniques;
drug production;
pharmaceutical process omics;
quality control
- MeSH:
Quality Control;
Humans;
Drugs, Chinese Herbal/chemistry*
- From:
China Journal of Chinese Materia Medica
2025;50(13):3628-3634
- CountryChina
- Language:Chinese
-
Abstract:
The quality of drugs is a crucial premise for ensuring the safety and effectiveness of clinical medication, while quality control during the pharmaceutical process directly affects the quality and consistency of the final product formulation. However, there is a lack of a comprehensive and scientific system for assessing and optimizing the quality control level during the manufacturing process in the field of drug quality control. Therefore, this study proposed the concept of "pharmaceutical process omics", clarified its advantages in guiding drug production, and explored in depth the research approaches, diverse analytical techniques, and broad range of applications in drug quality control. In addition, this study anticipated the broad application prospects of pharmaceutical process omics in the field of drug quality control, aiming to provide a scientific basis for the development of pharmaceutical process quality control standards.
