Effects of pharmaceutical excipients on CYP3A activity and its guiding effects on quality and efficacy consistency evaluation of generic drugs
10.12092/j.issn.1009-2501.2020.04.017
- VernacularTitle: 药用辅料对CYP3A活性的影响及其对仿制药质量和疗效一致性评价的指导作用
- Author:
Siyu CHEN
1
Author Information
1. Changsha DUXACT Co., Ltd.
- Publication Type:Journal Article
- Keywords:
Consistency evaluation;
CYP3A;
Pharmaceutical excipients
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(4):460-466
- CountryChina
- Language:Chinese
-
Abstract:
The prescription and technology of pharmaceutical preparations are the basis for ensuring the quality and efficacy of medicines. Pharmaceutical excipients are important part of pharmaceutical preparations. As it's known to all that some pharmaceutical excipients can affect the activity of CYP3A, and then may influence the metabolism and bioavailability of its substrates in vivo. Relative bioavailability is a key element of generic drug research in China and the United States. Our country is advancing the quality and efficacy consistency evaluation of generic drugs. Therefore, it is of great practical significance to understand the impact of pharmaceutical excipients on CYP3A and its guiding role in consistency evaluation.