As the central aspect of the pharmaceutical research and development process,the success of active pharmaceutical ingredient(API)process development directly impacts the quality,safety,and production efficiency of drugs.This paper briefly analyzes the basic procedure of API process development and explores the key issues and challenges faced during the process.Meanwhile,it discusses the characteristics of various stages of API process development,ranging from the preclinical phase to the clinical phase.Based on this,corresponding quality control strategies are proposed to ensure the consistent stability of API quality.
关键词
原料药/工艺开发/质量控制/医药化工
Key words
active pharmaceutical ingredient(API)/process development/quality control/pharmaceutical chemical industry
维普
万方数据