{"id":62445,"date":"2018-10-24T01:00:00","date_gmt":"2018-12-07T03:17:21","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/901d32f6d2\/"},"modified":"2018-12-07T11:17:22","modified_gmt":"2018-12-07T03:17:22","slug":"901d32f6d2","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/62445\/","title":{"rendered":"CDE\u516c\u5f00\u5f81\u6c42\u201c\u5c40\u90e8\u4f5c\u7528\u5e38\u89c1\u9634\u9053\u5236\u5242\uff08\u9634\u9053\u7247\u3001\u9634\u9053\u6813\uff09\u4eff\u5236\u836f\u7684\u8bc4\u4ef7\u6280\u672f\u8981\u6c42\u201d\u610f\u89c1"},"content":{"rendered":"
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2018\u5e7410\u670824\u65e5<\/p>\n

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3\u3001\u6279\u91cf<\/span><\/p>\n

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<\/span><\/p>\n

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\uff08\u4e00\uff09\u539f\u6599\u836f<\/span><\/p>\n

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\uff08\u4e8c\uff09\u8f85\u6599<\/span><\/p>\n

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\uff08\u4e09\uff09\u5305\u6750<\/span><\/p>\n

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\uff08\u56db\uff09\u539f\u8f85\u5305\u7684\u5173\u8054\u5ba1\u8bc4<\/span><\/p>\n

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1\u3001\u6027\u72b6<\/span><\/p>\n

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2\u3001pH\u503c\uff08\u9178\u5ea6\uff09<\/span><\/p>\n

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3\u3001\u878d\u53d8\u65f6\u9650<\/span><\/p>\n

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4\u3001\u6eb6\u51fa\u5ea6\uff08\u91ca\u653e\u5ea6\uff09<\/span><\/p>\n

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5\u3001\u4f53\u5916\u91ca\u653e\u8bd5\u9a8c<\/span><\/p>\n

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6\u3001\u6709\u5173\u7269\u8d28<\/span><\/p>\n

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6\u3001\u5fae\u751f\u7269\u9650\u5ea6<\/span><\/p>\n

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<\/span><\/p>\n

\u5341\u3001\u7a33\u5b9a\u6027\u7814\u7a76\u7684\u6280\u672f\u8981\u6c42<\/span><\/strong><\/p>\n

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<\/span><\/p>\n

\u5341\u4e00\u3001\u836f\u7406\u6bd2\u7406\u7814\u7a76\u7684\u6280\u672f\u8981\u6c42<\/span><\/strong><\/p>\n

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<\/span><\/p>\n

\u5341\u4e8c\u3001\u7b49\u6548\u6027\u8bc4\u4ef7\u65b9\u6cd5<\/span><\/strong><\/p>\n

\uff08\u4e00\uff09\u9634\u9053\u7247<\/span><\/p>\n

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2\u3001\u5728\u4eff\u5236\u836f\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08Q3\uff09\u4e00\u81f4\u7684\u524d\u63d0\u4e0b\uff0c\u82e5\u8f85\u6599\u79cd\u7c7b\uff08Q1\uff09\u76f8\u540c\u3001\u8f85\u6599\u7528\u91cf\uff08Q2\uff09\u4e0d\u76f8\u4f3c\uff0c\u6216\u4eff\u5236\u836f\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u8f85\u6599\u79cd\u7c7b\uff08Q1\uff09\u4e0d\u540c\uff0c\u5219\u5e94\u8fdb\u884c\u4ee5\u53c2\u6bd4\u5236\u5242\u4e3a\u5bf9\u7167\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u652f\u6301\u4eff\u5236\u54c1\u4e0e\u539f\u7814\u54c1\u5728\u4e34\u5e8a\u5b89\u5168\u6709\u6548\u6027\u65b9\u9762\u7684\u4e00\u81f4\u6027\u3002\u3002<\/span><\/p>\n

\uff08\u4e8c\uff09\u9634\u9053\u6813<\/span><\/p>\n

1\u3001\u82e5\u4eff\u5236\u836f\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u8f85\u6599\uff08\u4e0d\u5305\u62ec\u6291\u83cc\u5242\u3001\u6297\u6c27\u5242\uff09\u79cd\u7c7b\uff08Q1\uff09\u76f8\u540c\uff0c\u8f85\u6599\u7528\u91cf\uff08Q2\uff09\u76f8\u4f3c\uff0c\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08Q3\uff09\u4e00\u81f4\uff0c\u5e76\u8fdb\u884c\u4e86\u4e0e\u4e34\u5e8a\u5c40\u90e8\u4f5c\u7528\u76f8\u5173\u7684\u4f53\u5916\u91ca\u653e\u4e00\u81f4\u6027\u7814\u7a76\uff08\u5982\u6a21\u62df\u9634\u9053\u5236\u5242\u4f53\u5185\u91ca\u653e\u884c\u4e3a\u7684\u4f53\u5916\u91ca\u653e\u7814\u7a76\u7b49\uff09\uff0c\u7ecf\u6570\u636e\u8bc4\u4f30\u8bc1\u660e\u4f53\u5916\u91ca\u653e\u884c\u4e3a\u76f8\u4f3c\uff0c\u5219\u53ef\u4ee5\u63d0\u51fa\u8c41\u514d\u4e34\u5e8a\u7533\u8bf7\uff1b\u5982\u672a\u8bc1\u660e\u4f53\u5916\u91ca\u653e\u884c\u4e3a\u76f8\u4f3c\uff0c\u5219\u5e94\u8fdb\u884c\u4ee5\u53c2\u6bd4\u5236\u5242\u4e3a\u5bf9\u7167\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u652f\u6301\u4eff\u5236\u54c1\u4e0e\u539f\u7814\u54c1\u5728\u4e34\u5e8a\u5b89\u5168\u6709\u6548\u6027\u65b9\u9762\u7684\u4e00\u81f4\u6027\u3002<\/span><\/p>\n

2\u3001\u5728\u4eff\u5236\u836f\u4e0e\u53c2\u6bd4\u5236\u5242\u7684\u5173\u952e\u8d28\u91cf\u5c5e\u6027\uff08Q3\uff09\u4e00\u81f4\uff0c\u4e14\u57fa\u8d28\u79cd\u7c7b\u76f8\u540c\u3001\u57fa\u8d28\u7528\u91cf\u76f8\u4f3c\u7684\u524d\u63d0\u4e0b\uff0c\u82e5\u5176\u4ed6\u8f85\u6599\uff08\u4e0d\u5305\u62ec\u6291\u83cc\u5242\u3001\u6297\u6c27\u5242\uff09\u7684\u79cd\u7c7b\uff08Q1\uff09\u76f8\u540c\u3001\u8f85\u6599\u7528\u91cf\uff08Q2\uff09\u4e0d\u76f8\u4f3c\uff0c\u6216\u5176\u4ed6\u8f85\u6599\uff08\u4e0d\u5305\u62ec\u6291\u83cc\u5242\u3001\u6297\u6c27\u5242\uff09\u7684\u79cd\u7c7b\uff08Q1\uff09\u4e0d\u540c\uff0c\u5219\u5e94\u8fdb\u884c\u4ee5\u53c2\u6bd4\u5236\u5242\u4e3a\u5bf9\u7167\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u652f\u6301\u4eff\u5236\u54c1\u4e0e\u539f\u7814\u54c1\u5728\u4e34\u5e8a\u5b89\u5168\u6709\u6548\u6027\u65b9\u9762\u7684\u4e00\u81f4\u6027\u3002<\/span><\/p>\n

\uff08\u4e09\uff09\u5176\u4ed6<\/span><\/p>\n

1\u3001\u5bf9\u4e8e\u53ef\u80fd\u5b58\u5728\u5c40\u90e8\u7ed9\u836f\u7cfb\u7edf\u5438\u6536\u7684\u9ad8\u98ce\u9669\u5236\u5242\uff0c\u8fd8\u9700\u8fdb\u884c\u4ee5PK\u4e3a\u7ec8\u70b9\u7684BE\u7814\u7a76\uff0c\u4ee5\u8bc1\u660e\u53d7\u8bd5\u5236\u5242\u7684\u5168\u8eab\u66b4\u9732\u4e0d\u9ad8\u4e8e\u539f\u7814\u5236\u5242<\/span><\/p>\n

2\u3001\u5bf9\u4e8e\u5177\u6709\u7f13\u91ca\u4f5c\u7528\u7684\u5c40\u90e8\u5916\u7528\u5236\u5242\uff0c\u5e94\u8fdb\u884c\u4ee5\u53c2\u6bd4\u5236\u5242\u4e3a\u5bf9\u7167\u7684\u4e34\u5e8a\u8bd5\u9a8c\uff0c\u4ee5\u652f\u6301\u4eff\u5236\u54c1\u4e0e\u539f\u7814\u54c1\u5728\u4e34\u5e8a\u5b89\u5168\u6709\u6548\u6027\u65b9\u9762\u7684\u4e00\u81f4\u6027\u3002<\/span><\/p>\n

3\u3001\u5bf9\u4e8e\u5176\u4ed6\u7279\u6b8a\u60c5\u51b5\uff0c\u5efa\u8bae\u5177\u4f53\u95ee\u9898\u5177\u4f53\u5206\u6790\u3002<\/span><\/p>\n


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\u5341\u4e8c\u3001\u836f\u54c1\u8bf4\u660e\u4e66\u7684\u62df\u5b9a<\/span><\/strong><\/p>\n

\u5e94\u68c0\u7d22\u5e76\u8ffd\u8e2a\u53c2\u6bd4\u5236\u5242\u8bf4\u660e\u4e66\u53d8\u66f4\u60c5\u51b5\uff0c\u91c7\u7528\u6700\u65b0\u7248\u7684\u53c2\u6bd4\u5236\u5242\u8bf4\u660e\u4e66\uff0c\u62df\u5b9a\u836f\u54c1\u8bf4\u660e\u4e66\u3002<\/span><\/p>\n

  <\/span><\/p>\n

  <\/span><\/p>\n

\u53c2\u8003\u6587\u732e<\/span><\/strong><\/p>\n

[1]\u56fd\u5bb6\u836f\u5178\u59d4\u5458\u4f1a.\u4e2d\u534e\u4eba\u6c11\u5171\u548c\u56fd\u836f\u5178\uff3b\uff2d\uff3d.2015\u7248\u56db\u90e8.\u5317\u4eac:\u4e2d\u56fd\u533b\u836f\u79d1\u6280\u51fa\u7248\u793e, 2015.6.<\/span><\/p>\n

[2] BritishPharmacopoeia [M]. Online, 2017: General Notices<1164>.<\/span><\/p>\n

[3] JapanesePharmacopoeia 16[M].Online:General rules for preparations.<\/span><\/p>\n

[4] EMA. Notefor guidance on the clinical requirements for locally applied, locally actingproducts containing known constituents\uff08CPMP\/EWP\/239\/95\uff09.1995:http:\/\/www.emau.europa.eu.<\/span><\/p>\n

[5] EMA.Guideline on equivalence studies for the demonstration of therapeuticequivalence for produces that are locally applied, locally acting in thegastrointestinal tract as addendum to the guideline on the clinicalrequirements for locally applied, locally acting products containing knownconstituents\uff08CPMP\/EWP\/239\/95 Rev.1\uff09.2017:http:\/\/www.emau.europa.eu.<\/span><\/p>\n

[6]FDA.GDUFAregulatory science program public meeting. 2015: http:\/\/www.fda.gov\/.<\/span><\/p>\n

[7]FDA.Guidanceon Topical Dermatologic Corticosteroids: in vivo bioequivalence. 1995.6.<\/span><\/p>\n

[8]FDA.Equivalence of locally-acting drug products. 2017: http:\/\/www.fda.gov\/.<\/span><\/p>\n

[9]EMA.Guideline on the investigation of bioequivalence (CPMP\/EWP\/QWP\/1401\/98Rev.1\/Corr**). 2010.1.<\/span><\/p>\n

[10]EUClinical Trials Register. http:\/\/www.Clinical Trials Register.eu\/.<\/span><\/p>\n

[11]\u5d14\u798f\u5fb7.\u300a\u836f\u5242\u5b66\uff08\u7b2c7\u7248\uff09\u300b[M].\u4eba\u6c11\u536b\u751f\u51fa\u7248\u793e.2013\u5e74.<\/span><\/p>\n

[12]\u5e73\u5176\u80fd, \u5c60\u9521\u5fb7\uff0c\u5f20\u94a7\u5bff\u7b49.\u836f\u5242\u5b66. \u7b2c4\u7248[M].\u5317\u4eac\uff1a\u4eba\u6c11\u536b\u751f\u51fa\u7248\u793e. 2013\u5e74.<\/span><\/p>\n

[13]CFDA-CDE\u5ba1\u8bc4\u4e94\u90e8\u5ba1\u8bc4\u4e5d\u5ba4.\u5987\u79d1\u9634\u9053\u5c40\u90e8\u7528\u836f\u5236\u5242\u7814\u53d1\u4e2d\u5e38\u89c1\u95ee\u9898\u5206\u6790.2007.09.<\/span><\/p>\n

[14] CDE.\u300a\u5316\u5b66\u4eff\u5236\u836f\u6ce8\u518c\u6279\u751f\u4ea7\u89c4\u6a21\u7684\u4e00\u822c\u6027\u8981\u6c42\uff08\u8bd5\u884c\uff09\u300b\uff082018.6.22\uff09.<\/span><\/p>\n

[15]CFDA.\u300a\u5316\u5b66\u836f\u7269\uff08\u539f\u6599\u836f\u548c\u5236\u5242\uff09\u7a33\u5b9a\u6027\u7814\u7a76\u6280\u672f\u6307\u5bfc\u539f\u5219\u300b\uff082015.2.5\uff09.<\/span><\/p>\n

[16]FDA.Draft guidance on miconazole nitrate\uff0ehttp:\/\/www.fda.gov\/.<\/span><\/p>\n

[17] FDA.Draftguidance on terconazole\uff0ehttp:\/\/www.fda.gov\/.<\/span><\/p>\n

[18]FDA.CDERlabel, TERAZOL 3-terconazole suppository. http:\/\/www.fda.gov\/.<\/span><\/p>\n

[19]FDA.CDERlabel, MONISTAT 3-miconazole nitrate suppository. http:\/\/www.fda.gov\/.<\/span><\/p>\n

[20]FDA.CDERchemistry review(s),1999: Clindamycin phosphate vaginal suppositories,100mg.http:\/\/www.fda.gov\/.<\/span><\/p>\n

[21] EMA. Note for guidance on manufacture of thefinished dosage form(CPMP\/QWP\/486\/95). 1996: http:\/\/www.emau.europa.eu.<\/span><\/p>\n


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\u6765\u6e90\uff1aCDE<\/em><\/span><\/p>\n

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\"CDE\u516c\u5f00\u5f81\u6c42\u201c\u5c40\u90e8\u4f5c\u7528\u5e38\u89c1\u9634\u9053\u5236\u5242\uff08\u9634\u9053\u7247\u3001\u9634\u9053\u6813\uff09\u4eff\u5236\u836f\u7684\u8bc4\u4ef7\u6280\u672f\u8981\u6c42\u201d\u610f\u89c1\"<\/p>\n

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\"CDE\u516c\u5f00\u5f81\u6c42\u201c\u5c40\u90e8\u4f5c\u7528\u5e38\u89c1\u9634\u9053\u5236\u5242\uff08\u9634\u9053\u7247\u3001\u9634\u9053\u6813\uff09\u4eff\u5236\u836f\u7684\u8bc4\u4ef7\u6280\u672f\u8981\u6c42\u201d\u610f\u89c1\"<\/section>\n
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\u65b0\u836f&\u533b\u7597\u5668\u68b0<\/span><\/p>\n

\u4e00\u7ad9\u5f0f\u7efc\u5408\u670d\u52a1<\/span>CRO<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n

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<\/p>\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

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