寰炲椹楀鍒板晢妤�(y猫)鍖栵細閱�(y墨)钘ョ爺鐧�(f膩)浜烘墠鑱锋キ(y猫)鐧�(f膩)灞曞叏璺緫瑙ｆ瀽
鐧�(f膩)甯冩檪闁擄細2025-07-15
涓�銆�?? 鍒濋殠闅庢锛氱鐮斿熀绀�(ch菙)鑸囧钩鑷烘惌寤猴紙0-3骞达級
1. 涓昏宕椾綅
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宕椾綅
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鍏稿瀷鑱疯铂(z茅)
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甯歌瀛�(xu茅)姝疯儗鏅�
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鍒濈礆鐮旂┒鍝� / 鍔╃悊鐮旂┒鍝�
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瀵﹂鎿嶄綔銆佹暩(sh霉)鎿�(j霉)瑷橀寗銆佹枃鐛昏(di脿o)鐮�銆佸椹楁柟妗堝崝(xi茅)鍔�
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钘ュ(xu茅)銆佺敓鐗�銆侀啱(y墨)瀛�(xu茅)纰╁＋鎴栧劒(y艒u)绉�鏈
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鍒嗘瀽鐮旂┒鍝� / 瀵﹂瀹ゆ妧琛�(sh霉)鍝�
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鏂规硶闁嬬櫦(f膩)銆佹ǎ鍝佹娓�佸師濮嬫暩(sh霉)鎿�(j霉)鍒嗘瀽
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钘ョ墿鍒嗘瀽銆佸寲瀛�(xu茅)銆佺敓鐗╂妧琛�(sh霉)
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2. 鑳藉姏闂�(gu膩n)閸佃
- 鐔熺反鎿嶄綔瀵﹂瑷�(sh猫)鍌�
- 鎵庡鐨勮棩鐞�/钘ュ寲/鐢熺墿鍩虹(ch菙)
- 鑹ソ鐨勫椹楄閷勫拰鏂囩嵒闁辫畝鑳藉姏
3. 鑱锋キ(y猫)寤鸿
- 鏄庣⒑灏堟キ(y猫)鏂瑰悜锛氳棩鍖� vs 鐢熺墿鍒惰棩 vs 鍒嗘瀽绛夛紱
- 绌嶇疮闋呯洰缍�(j墨ng)椹楋紝鐖彇鍙冭垏灏堝埄/鏂囩珷鐧�(f膩)琛�/鐢冲牨鏉愭枡鎾板锛�
- 鍢楄│姗悜杓礂锛岀悊瑙ｆ暣鍊嬭棩鐗╃櫦(f膩)鐝�(xi脿n)娴佺▼銆�
浜�銆�?? 涓殠闅庢锛氶爡鐩富灏�(d菐o)鑸囧钩鑷烘(g貌u)寤猴紙3-7骞达級
1. 涓昏宕椾綅
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宕椾綅
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鏍稿績浠诲嫏(w霉)
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璺ㄧ晫鑳藉姏瑕佹眰
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鐮旂櫦(f膩)涓荤 / 绉戝(xu茅)瀹�
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瑷�(sh猫)瑷堝椹�銆佸付闅婂煼(zh铆)琛岄爡鐩�侀棞(gu膩n)閸垫暩(sh霉)鎿�(j霉)鍒嗘瀽銆佸牨鍛婃挵瀵�
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鎶�琛�(sh霉)+绠＄悊鍒濇绲�(ji茅)鍚�
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鑷ㄥ簥鍓嶈矤璨�(z茅)浜� / 璺ㄥ姛鑳�PM
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鍗�(xi茅)瑾�(di脿o)钘ユ晥銆佽棩浠�銆佹瘨鐞嗙瓑妯″鎺ㄩ��IND
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婧濋�氳兘鍔涘挤銆佷簡瑙�GLP/GMP
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CMC鐮旂┒鍝�
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钘ョ墿宸ヨ棟闁嬬櫦(f膩)銆佹妧琛�(sh霉)杞�(zhu菐n)绉�
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灏嶆帴鐢熺敘(ch菐n)銆�QA銆佹敞鍐婇儴闁�
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2. 鑳藉姏闂�(gu膩n)閸佃
- 闋呯洰瑕�(gu墨)鍔冭垏绠＄悊鑳藉姏
- 鍫卞憡鎾板銆�IND鏀寔缍�(j墨ng)椹�
- 鍒濇璺ㄥ(xu茅)绉戞簼閫氳兘鍔涳紙鑸囨敞鍐�銆佺敓鐢�(ch菐n)銆佽嚚搴婂皪鎺ワ級
3. 鑱锋キ(y猫)寤鸿
- 鏈夋剰璀樺煿椁�(y菐ng)“闋呯洰璨犺铂(z茅)浜�”鎬濈董锛�
- 閫愭鍙冭垏IND鐢冲牨鏉愭枡銆佸瑭曠瓟鐤�銆�CRO鍗�(xi茅)浣�锛�
- 鎷撳睍璺ㄩ儴闁�鍚堜綔缍�(j墨ng)椹楋紙CMC/娉ㄥ唺/鍚堣(gu墨)绛夛級銆�
涓�銆�?? 楂橀殠闅庢锛氳嚚搴婅綁(zhu菐n)鍖栬垏鍟嗘キ(y猫)鎴�(zh脿n)鐣ワ紙7骞翠互涓婏級
1. 涓昏宕椾綅
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宕椾綅
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闂�(gu膩n)閸佃伔璨�(z茅)
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鑳屾櫙瑕佹眰
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閱�(y墨)瀛�(xu茅)绺界洠(ji膩n) / 鑷ㄥ簥绺界洠(ji膩n)
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瑷�(sh猫)瑷堣│椹楁柟妗�銆佺洠(ji膩n)绠¤嚚搴婂煼(zh铆)琛�銆佽В璁�鏁�(sh霉)鎿�(j霉)
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鑷ㄥ簥閱�(y墨)瀛�(xu茅)/钘ョ悊纰╁崥锛屾噦娉ㄥ唺娉曡(gu墨)
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娉ㄥ唺绺界洠(ji膩n) / 娉曡(gu墨)浜嬪嫏(w霉)绺界洠(ji膩n)
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涓诲皫(d菐o)IND/NDA/BLA娉ㄥ唺銆佽垏鐩�(ji膩n)绠℃妲�(g貌u)婧濋��
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鐔熸倝NMPA/FDA/EMA娉曡(gu墨)
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CMC绺界洠(ji膩n)
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鎶�琛�(sh霉)杞�(zhu菐n)绉汇�佽唱(zh矛)閲忛珨绯绘惌寤�銆�GMP鐢熺敘(ch菐n)鏀寔
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鎶�琛�(sh霉)+绠＄悊鑳屾櫙
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鎴�(zh脿n)鐣ョ爺鐧�(f膩)璨犺铂(z茅)浜� / 鑱�(li谩n)鍚堝壍(chu脿ng)濮嬩汉锛�CSO锛�
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鎶婃帶绠＄窔鏂瑰悜銆佸皪鎺ヨ硣鏈�銆佹暣鍚堣硣婧�
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鎶�琛�(sh霉)+鎴�(zh脿n)鐣�+璩囨湰瑕栭噹
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2. 鑳藉姏闂�(gu膩n)閸佃
- “鐮旂櫦(f膩)+鑷ㄥ簥+娉ㄥ唺”涓�楂斿寲绠＄悊鑳藉姏
- 鑳藉?q奴)顬�?span lang="EN-US">CRO銆�CDE銆�FDA绛夊閮ㄦ妲�(g貌u)
- 鑻辨枃璩囨枡鎾板鑸囨簼閫氳兘鍔�
3. 鑱锋キ(y猫)寤鸿
- 璺冲嚭绱旀妧琛�(sh霉)锛屽悜“娉ㄥ唺+鑷ㄥ簥+鍟嗘キ(y猫)鍖�”鍏ㄩ張姊濇摯灞�锛�
- 闂�(gu膩n)娉ㄩ啱(y墨)钘ユ斂绛�銆佽硣鏈�銆佸嚭娴风瓑鍓嶆部鍕曟厠(t脿i)锛�
- 鍩归(y菐ng)鍚�“CDO/CSO/COO”鐧�(f膩)灞曠殑鎴�(zh脿n)鐣ユ牸灞�銆�
鍥�銆�?? 鍟嗘キ(y猫)鍖栬綁(zhu菐n)鍨嬫柟鍚戣垏澶氬厓鍑鸿矾
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鏂瑰悜
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閬╁悎浜虹兢
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鐧�(f膩)灞曟鏈�
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钘ヤ紒楂樼锛�CSO/CDO锛�
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鍏峰倷鎶�琛�(sh霉)+绠＄悊+绠＄窔鍒ゆ柗鍔�
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鍦嬪収(n猫i)鍓�(chu脿ng)鏂拌棩浼併�佸嚭娴峰钩鑷�
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鎶曡硣浜� / 閱�(y墨)钘�FA
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鐔熸倝鎶�琛�(sh霉)鍙堟噦鐢�(ch菐n)妤�(y猫)
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鍓�(chu脿ng)鎶曟妲�(g貌u)銆佸苟璩煎熀閲�銆佸挩瑭㈠叕鍙�
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BD鑸囪法澧冨悎浣�
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鑻辫獮寮�+鍦嬮殯瑕栭噹+鎳傛妧琛�(sh霉)
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钘ヤ紒鍑烘捣銆佸湅闅涙巿娆�(qu谩n)鍦橀殜
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閱�(y墨)鐧傛斂绛� / 钘ユ斂鍚堣(gu墨)
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鏈夌敵鍫辫垏娉曡(gu墨)缍�(j墨ng)椹�
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鏀跨瓥鐮旂┒姗熸(g貌u)銆佽法鍦嬭棩浼佹硶瑕�(gu墨)閮�
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浜斻��?? 钖叕瓒ㄥ嫝鍙冭�冿紙閮ㄥ垎宕椾綅锛屽柈浣嶏細骞磋柂锛屼汉姘戝梗锛�
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宕椾綅
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涓�绶氬煄甯�3-5骞�
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5-8骞�
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8骞翠互涓婃垨绺界洠(ji膩n)绱�
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鐮旂櫦(f膩)绉戝(xu茅)瀹�
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30-50钀�
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60-90钀�
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100-150钀�
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鑷ㄥ簥闋呯洰缍�(j墨ng)鐞�
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40-70钀�
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80-120钀�
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150-200钀�
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娉ㄥ唺/娉曡(gu墨)浜嬪嫏(w霉)
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50-80钀�
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90-130钀�
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150-250钀�
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CMC璨犺铂(z茅)浜�
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50-90钀�
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100-160钀�
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180-300钀�
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CSO/CDO
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-
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-
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250-500钀�+鑲℃瑠(qu谩n)
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绺界祼(ji茅)锛氶啱(y墨)钘ョ爺鐧�(f膩)浜烘墠鑱锋キ(y猫)閫查殠璺緫涓夎绱�
1. 鎶�琛�(sh霉)+闋呯洰+娉曡(gu墨)锛氫笉鍍呰鎳傚椹楋紝鏇磋鏈冩帹閫查爡鐩苟绗﹀悎鑷ㄥ簥鍜屾敞鍐婂悎瑕�(gu墨)瑕佹眰锛�
2. 瑕栭噹+琛ㄩ仈+鑻辨枃鑳藉姏锛氬叿鍌欒法鑱疯兘婧濋�氬姏锛屾槸閭佸悜楂樺堡鐨勫垎姘村逗锛�
3. 灏堟キ(y猫)+鎴�(zh脿n)鐣�锛氭噦鎶�琛�(sh霉)鐨勪汉澶�锛岃兘甯堕殜銆佸畾鏂瑰悜銆佺鍟嗘キ(y猫)鐨勬墠绋�缂�銆�