中藥新藥臨床研究一般原則含目錄

1、— 1 ——附件 1中藥新藥臨床研究一般原則(2015 年 11 月 3 日-CFDA 發(fā)布)一、概述.............................................................................................................................................................4二、倫理學(xué)及受試者的保

2、護.............................................................................................................................5三、中藥新藥臨床試驗的特點................................................................................

3、.........................................6四、中藥新藥臨床試驗計劃的制定及研發(fā)風(fēng)險的控制 .................................................................................7（一）藥物的臨床定位..............................................................

4、...................................................................7（二）臨床試驗設(shè)計方法的科學(xué)性.............................................................................................................8（三）早期探索性臨床試驗...............

5、..........................................................................................................8（四）臨床試驗質(zhì)量控制......................................................................................................

6、.......................8五、風(fēng)險/受益評估 ...........................................................................................................................................9（一）開展風(fēng)險/受益評估的要求 ..............................

7、.................................................................................9（二）風(fēng)險/受益評估重點 .........................................................................................................................11（三

8、）風(fēng)險/受益評估原則 .........................................................................................................................12六、中藥新藥Ⅰ期人體耐受性試驗設(shè)計 ....................................................................

9、...................................14（一）I 期人體耐受性試驗設(shè)計要點.........................................................................................................14（二）不良事件/不良反應(yīng)的觀察與判斷 ........................................

10、.........................................................21（三）Ⅰ期耐受性試驗的總結(jié)要點...........................................................................................................21（四）Ⅰ期耐受性試驗中應(yīng)注意的問題....................

11、...............................................................................22七、中藥新藥臨床試驗設(shè)計的一般考慮 .......................................................................................................23— 3 ——（九）肝損傷病例應(yīng)收

12、集的內(nèi)容...............................................................................................................80（十）藥物性肝損傷與“肝臟生化學(xué)檢查異?！钡膮^(qū)別 .......................................................................82十一、心臟

13、安全性評價要求...........................................................................................................................83（一）中藥導(dǎo)致相關(guān)藥物性心臟損傷的可能原因 ..................................................................

14、.................83（二）藥物性心臟損傷的診斷...................................................................................................................83（三）藥物性心臟損傷程度的評價標(biāo)準(zhǔn)......................................................

15、.............................................84（四）心臟安全性評價指標(biāo).......................................................................................................................84（五）心臟安全性評價時的注意事項........................

16、...............................................................................86（六）受試者安全的保護措施...................................................................................................................86十二、腎臟安全性評

17、價要求...........................................................................................................................87（一）藥物性腎損傷的發(fā)病機制..............................................................................

18、.................................88（二）藥物性腎損傷的診斷依據(jù)...............................................................................................................88（三）藥物性腎損傷的診斷與分級標(biāo)準(zhǔn).........................................

19、..........................................................89（四）腎臟安全性評價指標(biāo).......................................................................................................................91（五）藥物性腎損傷的處理原則.............

20、..................................................................................................93十三、參考文獻.................................................................................................................