本文選題：肝癌 + 新藥研發(fā)��； 參考：《天津大學》2014年博士論文

【摘要】：肝癌是世界上第三大死亡癌癥，是我國第二大發(fā)病惡性腫瘤。治療肝癌的藥物較少，近些年，F(xiàn)DA僅批準了索拉非尼作為肝癌治療藥物，這也說明肝癌藥物研發(fā)存在眾多風險。本文在肝癌特征分析及相應藥物研發(fā)現(xiàn)狀分析的基礎上，提出了目前抗肝癌藥物的研發(fā)風險。采用調查問卷的形式，針對不同人群及這些風險因素，提出相應對策，在此基礎上設計了關于研發(fā)風險的系統(tǒng)軟件，用以評價新藥的研發(fā)風險，并對目前在研的藥物進行了初步的風險評估。 抗肝癌新藥研發(fā)是一個復雜而動態(tài)的過程，通過調查問卷的形式，發(fā)現(xiàn)在研發(fā)階段，技術創(chuàng)新能力、技術平臺、技術壽命、生產操作人員的水平、藥物篩選決策、信息溝通、融資風險和人才風險呈現(xiàn)發(fā)生概率大，影響程度大的趨勢；在生產階段原料供應和工藝設備風險占主要地位；在新藥銷售階段市場占有率、競爭對手、商業(yè)運作和不良反應風險則起著決定作用。 采用加權分析結合主成分分析的方法對新藥研發(fā)的風險進行了量化分析，提高了分析的準確性。主要從環(huán)境、技術、生產、決策、財務、管理、市場七方面提出抗肝癌新藥研發(fā)項目的風險應對策略。通過對抗肝癌新藥研發(fā)現(xiàn)狀的分析及風險評估等，最終設計了抗肝癌新藥研發(fā)的風險管理流程。發(fā)現(xiàn)在創(chuàng)新藥物的研發(fā)階段，技術創(chuàng)新能力、技術服務平臺、藥物篩選決策等風險呈現(xiàn)發(fā)生概率大，影響程度大的趨勢，，是企業(yè)在新藥品種開發(fā)前需要優(yōu)先要考慮的因素。 鑒于創(chuàng)新藥物研發(fā)階段的風險評估在整個新藥品種研發(fā)階段中處于至關重要的地位，設計并創(chuàng)制了創(chuàng)新藥研發(fā)評估系統(tǒng)，并對在研的5種新藥，通過研發(fā)人員定期提交的文本材料，采用自動評估與領域專家選擇性審核方式確定研發(fā)品種的進展情況。結果表明，抗肝癌藥物CT102、中藥5類抗癌新藥白頭翁皂苷及其制劑的研發(fā)成果優(yōu)異，可在后期加大資金資助力度；SL01-一種吉西他濱前藥，靶向抗腫瘤一類新藥NX125兩個項目進展順利，應進一步加強實時跟蹤；遼東id木葉總皂苷膠囊抗腫瘤新藥項目課題的進展明顯落后于其他類似課題，經過系統(tǒng)評估，此項目有必要及時中止，以進一步降低風險。
[Abstract]:Liver cancer is the third leading cancer in the world and the second most malignant tumor in China. There are fewer drugs to treat liver cancer, and in recent years the FDA has only approved Solafenib as a treatment for liver cancer, suggesting that there are many risks in the development of drugs for liver cancer. Based on the analysis of the characteristics of liver cancer and the current situation of drug research and development, this paper puts forward the research and development risk of antihepatoma drugs. In the form of questionnaire, the corresponding countermeasures are put forward for different population groups and these risk factors. On this basis, a systematic software on R & D risk is designed to evaluate the R & D risk of new drugs. A preliminary risk assessment of the drugs currently under study was also carried out. The research and development of new anti-liver cancer drugs is a complicated and dynamic process. Through the form of questionnaire, we find that in the research and development stage, the technological innovation ability, the technology platform, the technical life span, the level of the production operator, the drug screening decision, the information communication, Financing risk and talent risk show a trend of large occurrence probability and great influence degree; raw material supply and process equipment risk occupy the main position in the production phase; market share in the new drug sales phase, competitors, Business operations and adverse reaction risks play a decisive role. The method of weighted analysis combined with principal component analysis (PCA) was used to quantify the risk of new drug research and development, and the accuracy of the analysis was improved. This paper puts forward the risk response strategy of new drug development project of anti-liver cancer from seven aspects: environment, technology, production, decision making, finance, management and market. Based on the analysis and risk assessment of the status quo of new drug development against liver cancer, the risk management process of new drug development for anti-liver cancer was designed. It is found that in the stage of research and development of innovative drugs, technological innovation ability, technical service platform, drug screening decision and other risks present a trend of large probability and great influence, which is the first factor that enterprises should consider before the development of new drug varieties. In view of the critical position of risk assessment in the phase of research and development of innovative drugs throughout the research and development phase of new drugs, an evaluation system for the development and development of innovative drugs has been designed and created, and five new drugs under study have been designed and developed. The progress of R & D products is determined by automatic evaluation and selective audit of field experts through the regular submissions of R & D personnel. The results showed that CT102, a new anticancer drug of traditional Chinese medicine, had excellent results in the research and development of saponins and their preparations, and could increase financial support to SL01- a gemcitabine predrug in the later stage. The two projects, NX125, a new anti-tumor drug, are progressing smoothly, and real-time tracking should be further strengthened. The progress of the new anti-tumor drug project of id total saponins capsule in Liaodong is obviously lagging behind that of other similar projects, and has been systematically evaluated. It is necessary to stop the project in time to further reduce the risk.
【學位授予單位】：天津大學
【學位級別】：博士
【學位授予年份】：2014
【分類號】：R95

【參考文獻】

相關期刊論文 前10條

1 周愛萍;孫燕;;多靶點抗腫瘤新藥索拉非尼的研究進展[J];癌癥進展;2006年06期

2 連波;莫非凡;;對國有企業(yè)風險監(jiān)控體系的思考[J];財政監(jiān)督;2010年12期

3 魏選平,卞樹檀;故障樹分析法及其應用[J];電子產品可靠性與環(huán)境試驗;2004年03期

4 程書權;郭長海;;原發(fā)性肝癌的藥物治療[J];世界臨床藥物;2007年11期

5 勞本信;劉寧杰;何慶光;;基于模糊風險綜合評價法的ERP項目風險評價[J];廣西財經學院學報;2006年04期

6 劉斐;商倩;張士俊;;中藥活性成分抗肝癌的研究進展[J];現(xiàn)代藥物與臨床;2012年06期

7 姚新生,胡柯;中藥復方的現(xiàn)代化研究[J];化學進展;1999年02期

8 金麗麗;黃琦;田兵權;;SWOT分析法在項目風險管理中的應用[J];建筑設計管理;2007年02期

9 馬雪青;;制藥企業(yè)創(chuàng)新藥物研發(fā)的風險管理[J];會計之友(B);2005年02期

10 楊朝旭;秦叔逵;;奧沙利鉑治療原發(fā)性肝癌的臨床研究進展[J];臨床腫瘤學雜志;2010年09期

相關博士學位論文 前1條

1 李永州;中醫(yī)治療肝癌方藥的篩選評估研究[D];廣州中醫(yī)藥大學;2011年

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