【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 quality target product profile (Q
【机 构】
：
沈阳药科大学;深圳万乐药业有限公司
【出 处】
：
第二届全国生物颗粒学术研讨会、第三届国际工业药学和临床药学研讨会暨第一届岭南国际药学大会
论文部分内容阅读
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 quality target product profile (QTPP), critical quality attributes (CQAs), critical material attributes (CMAs), critical process parameters(CPPs), design of experiment (DOE), process analytical technology (PAT), etc..The specific research steps are as follows:(1) The implementation of QbD begins with predefined objectives by assessment of the reference listed drug (RLD).The information of the RLD, such as, identity, assay and uniformity, moisture content, stability, dissolution profile, pharmacokinetics (Cmax, Tmax, AUC), etc., can provide the useful information for development of generic new drug and equivalent assessment.(2) Identification of QTPP and CQA of the target product based on the properties of the drug substance and characterization of the RLD product, and by the risk assessment.Pharmaceutical development focused on those CQAs that could be impacted by a change to the CMAs and CPPs.(3) Pre-formulation: ①Understanding and study on the materials attributes and excipients characteristics (physical, chemical, biological properties);②Identification of the CMAs by risk assessment to the CQAs;③ Selection of suitable excipients through investigation of compatibility of the drug and the excipients.(4) Formulation development: Including initial risk assessment of the formulation variables (such as amount of excipient, particle size, etc.), DOE and data analysis.The DOE models were used to establish acceptable ranges for formulation variables.(5) Manufacturing process development: Including identification of the CPPs by risk assessment to the CQAs and fied out an appropriate range for each CPP depending on the DOE and data analysis;(6) Scale up and control strategy: PAT is applicable to produce consistent quality over time.Finally, product and process capability is assessed and continually improved postapproval during product lifecycle management.
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