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| QbD application in drug research and development |
| SU Xian1 GAO Yunjia2 |
1.Clinical Research Institute, Peking University, Beijing 100191, China;
2.Center for Modernization of Traditional Chinese Medicine, Peking University, Beijing 100191, China |
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Abstract Quality by design (QbD) has become a new method combinate science with quality risk in drug research and development, driveing by guidelines do ICH and FDA. This paper analyzes the purpose of QbD, summarizes six elements to implement QbD, lists the currently popular QbD tools to opreation: prior knowledge, risk assessment, mechanical model, process analytical technology, design of experiments and data analysis, and summarizes the situation of the FDA's implement QbD and benefit. Be acknowleged by international registration and drug research and development, QbD will improve the quality of China's pharmaceutical industry. CFDA is implementing regulatory laws and related technical guidances gradually realize international conformity.
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