[lecture] Application of toxicity prediction software to meet ICH M7 guidelines

At the end of January 2019, the National Pharmacopoeia Committee issued four draft for comments, including "review draft of guidelines for control of genotoxic impurities (New)" From the draft, we can see that China's requirements for the control of genotoxic impurities have been in line with international standards, and the basic guidelines have been consistent with ichm7 The guidelines provide reference for the revision of drug standards and the reevaluation of drug safety on the market The identification, classification and classification control of impurities are specified in ichm7 According to the different risk levels of impurities, the M7 guiding principle divides them into five different levels, and allows the classification of impurities by computer simulation prediction method Therefore, the risk and cost of enterprises can be greatly reduced by classifying impurities with software conforming to ichm7 This lecture focuses on the application of Derek and Sarah, the authoritative toxicity prediction software recognized by regulatory agencies of various countries, in impurity classification 1、 Presenter of live broadcast information: Lin Weiyu host: Xi live broadcast platform: YY channel 33977027 live broadcast platform: Yingke live broadcast No 718244951 time: 20:00-21:30, April 23, 2019 registration address: https://edu.yaozh.com/course/125.html (you can receive the opening reminder after registration) II Course Outline 1 Introduce the guiding principles of ichm7; 2 Two complementary toxicity prediction methods; - Prediction System Based on expert knowledge rules; - Prediction System Based on statistical principles; 3 Expert review based on prediction results; 4 Specific application and case analysis of ichm7 3、 Lin Weiyu, graduated from China Pharmaceutical University, is currently the manager of computer aided drug design department of kangyusheng Information Technology Co., Ltd Since joining the company in 2011, he has been responsible for the technical support and product use training of "computer aided drug design department" Proficient in various software tools of computer-aided drug design, responsible for technical support of GSK, JNJ, Abbott, Hengrui, Zhengda Tianqing, Kelun and other companies in China for a long time, as well as technical support of Peking University, Xiehe, Jiaotong University, Central South University and other domestic universities The main research fields include: drug design, compound toxicity research, chemical informatics, macromolecular drug design, etc 4、 Ways of attention: 1 Wechat, Weibo: Official wechat (yaozh008), official Weibo (yaozhi.com) 2 QQ group of communication of pharmaceutical Intelligence College: 339420479