Application of QbD and RLD on generic product development of oral administration

摘要：

QbD (quality by design) is scientific, risk-based, holistic and systematic approach to develop generic new drug.The key elements of pharmaceutical QbD can include the QTPP,product design and understanding, process design and understanding, and scale up, control strategy, and continual improvement.

作者: Fude Cui

作者单位: Shenyang pharmaceutical university, Shenyang, China

会议类型: 国际会议

会议名称: The 4th Asian Symposium on Pharmaceutical Science and Technology & Enlarged Editorial Board Conference of the Asian Journal of Pharmaceutical Sciences (第四届亚洲药剂学论坛暨亚洲药物制剂科学杂志编委会扩大会议)

会议地点: 沈阳

会议语种:英文

页码: 167-168

在线出版日期: 2016-04-28（万方平台首次上网日期，不代表论文的发表时间）