{"id":98847,"date":"2019-05-09T00:00:50","date_gmt":"2019-05-17T08:17:12","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/98847\/"},"modified":"2019-05-17T16:17:14","modified_gmt":"2019-05-17T08:17:14","slug":"96b977c938","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/98847\/","title":{"rendered":"\u3010\u8bae\u7a0b\u30112019\u5236\u5242\u4e0e\u836f\u4ee3\u52a8\u529b\u5b66\u5efa\u6a21\u4e0e\u6a21\u62dfGastroPlus\u57f9\u8bad\u73ed"},"content":{"rendered":"
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2019 \u5236\u5242\u4e0e\u836f\u4ee3\u52a8\u529b\u5b66\u5efa\u6a21\u4e0e\u6a21\u62dfGastroPlus\u57f9\u8bad\u73ed<\/strong><\/p>\n

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\u5236\u5242Formulation\u73ed<\/p>\n

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Laptop\/\u57f9\u8bad\u7535\u8111<\/strong><\/p>\n<\/section>\n

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Attendees will need take Laptop by yourself<\/span><\/section>\n

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Location\/\u57f9\u8bad\u5730\u70b9\u4e0e\u4ea4\u901a<\/span><\/strong><\/p>\n<\/section>\n

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\u5730  \u94c1:<\/strong>2\u53f7\u7ebf\u5f20\u6c5f\u9ad8\u79d15\u53f7\u53e3\u51fa\uff0c\u6b65\u884c\u7ea610\u5206\u949f<\/span><\/section>\n
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Hotel\/\u5468\u8fb9\u4f4f\u5bbf<\/strong><\/p>\n<\/section>\n

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Contact\/\u4e3b\u529e\u65b9\u8054\u7cfb\u4eba<\/strong><\/p>\n<\/section>\n

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\u8054\u7cfb\u4eba\uff1a\u77f3\u7426                        <\/span><\/section>\n

\u7535\u8bdd\uff1a021-5026 3208<\/span><\/section>\n
EMAIL\uff1aJennieshi@pharmogo.com       <\/span><\/section>\n
Q Q\uff1a1114996120<\/span><\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n
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Agenda \u8bae\u7a0b<\/strong><\/p>\n<\/section>\n

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Each Section includes introduction, Case study, Hands on \u6bcf\u4e2a\u7ae0\u8282\u542b\u539f\u7406\u8bb2\u89e3\u3001\u6848\u4f8b\u3001\u4e0a\u673a\u64cd\u4f5c<\/strong><\/p>\n

SLP-\u7f8e\u56fdSimulations Plus<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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5\u670815\u65e5\u5468\u4e09<\/span><\/strong><\/p>\n

8:00-9:00<\/strong> <\/p>\n

Registration \u6ce8\u518c<\/span><\/p>\n

9:00-9:50 <\/span>\u9648\u6d9b\uff0c<\/span><\/span><\/strong><\/p>\n

The introduction of GastroPlus basic applications, modeling parameters and operations<\/span><\/p>\n

GastroPlus\u57fa\u672c\u5e94\u7528\u3001\u6a21\u578b\u53c2\u6570\u3001\u8f6f\u4ef6\u64cd\u4f5c\u4ecb\u7ecd<\/p>\n

9:50-10:00 Tea break <\/span>\u8336\u6b47<\/span><\/strong><\/p>\n

10:00-11:40  \u8bb8\u53ef\uff0cSLP<\/span><\/strong><\/p>\n

The theory and applications of GastroPlus solubility, dissolution and absorption process<\/p>\n

GastroPlus\u8003\u5bdf\u836f\u7269\u6eb6\u89e3\u3001\u6eb6\u51fa\u4e0e\u5438\u6536\u8fc7\u7a0b\u7684\u7406\u8bba\u4e0e\u5e94\u7528<\/p>\n

11:40-12:40  Lunch \u5348\u9910<\/span><\/strong><\/p>\n

12:40-13:00  Group Photo\u5408\u7167<\/span><\/strong><\/p>\n

13:00-15:00  \u5468\u6d77\u82f1\uff0cSLP<\/strong><\/span><\/p>\n

The theory and applications of GastroPlus distribution and elimination process<\/p>\n

GastroPlus\u8003\u5bdf\u836f\u7269\u5206\u5e03\u4e0e\u6e05\u9664\u8fc7\u7a0b\u7684\u7406\u8bba\u4e0e\u5e94\u7528<\/p>\n

15:00-15:10  Tea break \u8336\u6b47<\/span><\/strong><\/p>\n

15:10-16:10  \u9648\u6d9b\uff0c<\/span><\/strong><\/p>\n

Case study-Predict invivo PK profile based on Compartmental PK model<\/p>\n

\u5e94\u7528\u6848\u4f8b-\u57fa\u4e8e\u7ecf\u5178\u623f\u5ba4\u6a21\u578b\u9884\u6d4b\u836f\u7269\u4f53\u5185\u836f\u4ee3\u66f2\u7ebf<\/p>\n

16:10-16:20  <\/span>Tea break \u8336\u6b47<\/span><\/strong><\/p>\n

16:20-17:30   \u8bb8\u53ef\uff0cSLP<\/span><\/strong><\/p>\n

Case study-Predict human PK profile based on in vitro data and PBPK model<\/span><\/p>\n

\u5e94\u7528\u6848\u4f8b-\u7ed3\u5408\u4f53\u5916\u6570\u636e\u548c\u751f\u7406\u836f\u4ee3\u52a8\u529b\u5b66\u6a21\u578b\u9884\u6d4b\u836f\u7269\u5728\u4eba\u4f53\u7684PK\u66f2\u7ebf<\/p>\n

17:30-18:00  <\/strong>Panel discussion \u5206\u7ec4\u8ba8\u8bba\u4e0e\u4e92\u52a8<\/span><\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u7b2c2-3\u5929-\u5236\u5242Formulation\u73ed<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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5\u670816\u65e5\u5468\u56db<\/span><\/strong><\/p>\n

9:00-10:30 \u8bb8\u53ef\uff0cSLP<\/strong><\/p>\n

Case study-Guide formulation development based on food effect prediction and sensitive parameters analysis<\/p>\n

\u98df\u7269\u6548\u5e94\u9884\u6d4b\u3001\u53c2\u6570\u654f\u611f\u6027\u5206\u6790\u4ee5\u6307\u5bfc\u5236\u5242\u5904\u65b9\u5f00\u53d1 <\/p>\n

10:30-10:40 Tea break \u8336\u6b47<\/strong><\/p>\n

10:40-12:00 \u8bb8\u53ef\uff0cSLP<\/strong><\/p>\n

Optimizing formulation (release rate) to hit therapeutic concentration windows<\/p>\n

\u4f18\u5316\u5236\u5242\u91ca\u653e\u901f\u7387\u4ee5\u8fbe\u5230\u5408\u9002\u7684\u6cbb\u7597\u7a97<\/p>\n

12:00-13:00 Lunch \u5348\u9910<\/strong>
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13:00-14:30  \u8bb8\u53ef\uff0cSLP<\/strong><\/p>\n

Predict in vivo ADME process of transdermal or pulmonary dosage forms and guide the formulation design<\/p>\n

\u9884\u6d4b\u7ecf\u76ae\u53ca\u80ba\u90e8\u7ed9\u836f\u5236\u5242\u7684\u4f53\u5185ADME\u8fc7\u7a0b\uff0c\u6307\u5bfc\u5236\u5242\u5904\u65b9\u8bbe\u8ba1 <\/p>\n

14:30-14:40 Tea break\u8336\u6b47<\/strong><\/p>\n

14:40-15:50\u8bb8\u5c24\u65b0\uff0c<\/strong><\/p>\n

The introduction to DDDPlus basic applications and operation (in vitro dissolution modeling program)<\/p>\n

\u4f53\u5916\u6eb6\u51fa\u6a21\u578bDDDPlus\u8f6f\u4ef6\u7684\u57fa\u672c\u4ecb\u7ecd\u548c\u64cd\u4f5c <\/p>\n

15:50-16:00 Tea break\u8336\u6b47<\/strong><\/p>\n

16:00-17:00 \u8bb8\u5c24\u65b0\uff0c<\/strong><\/p>\n

Case study-Optimize formulation composition and develop dissolution condition<\/p>\n

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17:00-17:30 Panel discussion \u5206\u7ec4\u8ba8\u8bba\u4e0e\u4e92\u52a8<\/strong><\/p>\n

18:00-20:30 Dinner party \u665a\u5bb4<\/strong><\/p>\n

5\u670817\u65e5\u5468\u4e94<\/strong><\/span><\/p>\n

8:30-10:10  \u5468\u6d77\u82f1\uff0cSLP<\/strong><\/p>\n

Build and evaluate in vitro and in vivo correlation\/relationship model (z-factor and IVIVC\/IVIVR model)<\/p>\n

\u5efa\u7acb\u5236\u5242\u4f53\u5185\u5916\u76f8\u5173\u6027IVIVC\/IVIVR\u6a21\u578b<\/p>\n

10:10-10:20 Tea break \u8336\u6b47<\/strong><\/p>\n

10:20-11:30 \u5468\u6d77\u82f1\uff0cSLP<\/strong><\/p>\n

Virtual BE study to evaluate test formulation<\/p>\n

\u4eff\u5236\u836f\u865a\u62df\u751f\u7269\u7b49\u6548\u6027\u8bc4\u4f30 <\/p>\n

11:30-12:30 Lunch \u5348\u9910<\/strong><\/p>\n

12:30-14:00 \u5468\u6d77\u82f1\uff0cSLP<\/strong><\/p>\n

Predict in vivo precipitation and human PK profiles based on GastroPlus PBPK model and DDDPlus biphasic dissolution model<\/p>\n

\u8054\u5408GastroPlus\u548cDDDPlus\u53cc\u76f8\u6eb6\u51fa\u6a21\u578b\u8003\u5bdf\u836f\u7269\u4f53\u5185\u6c89\u6dc0\u4ee5\u53ca\u9884\u6d4b\u4e0d\u540c\u5242\u91cf\u7ed9\u836f\u540e\u7684PK\u66f2\u7ebf<\/p>\n

14:00-14:10 Tea break \u8336\u6b47<\/strong><\/p>\n

14:10-15:30  \u9648\u6d9b\uff0c<\/span><\/span><\/strong><\/p>\n

Case study-Raw data inputs, modeling and analysis, data supplement and assumption, result applications
<\/p>\n

\u6848\u4f8b\u5206\u4eab-\u539f\u59cb\u6570\u636e\u8f93\u5165\u3001\u6a21\u578b\u642d\u5efa\u3001\u9884\u6d4b\u504f\u5dee\u5206\u6790\u3001\u6570\u636e\u8865\u5145\u3001\u5047\u8bbe\u4e0e\u8c03\u6574\u3001\u7ed3\u679c\u5e94\u7528\u7b49 <\/p>\n

15:30-16:00 Panel discussion \u5206\u7ec4\u95ee\u9898\u62a2\u7b54<\/strong><\/p>\n

16:00-16:30 Certificae & Awards \u9881\u53d1\u8bc1\u4e66\u4e0e\u9881\u5956<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u7b2c2-3\u5929- DMPK\u4e0e\u4e34\u5e8a\u836f\u7406\u73ed<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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5\u670816\u65e5\u5468\u56db<\/strong><\/span><\/p>\n

9:00-10:30 \u5468\u6d77\u82f1\uff0cSLP<\/strong><\/p>\n

Build PK\/PBPK-PD model and predict drug effect after dosage form or dose is changed<\/p>\n

\u642d\u5efa\u836f\u7269\u7684PK\/PBPK-PD\u7ed3\u5408\u6a21\u578b\uff0c\u9884\u6d4b\u5242\u578b\u3001\u5242\u91cf\u7b49\u7ed9\u836f\u65b9\u6848\u6539\u53d8\u540e\u5bf9\u836f\u6548\u7684\u5f71\u54cd <\/p>\n

10:30-10:40 Tea break\u8336\u6b47<\/strong><\/p>\n

10:40-12:00 \u5468\u6d77\u82f1\uff0cSLP<\/strong><\/p>\n

Predict in vivo PK of McAb by GastroPlus PBPK model<\/p>\n

\u57fa\u4e8ePBPK\u6a21\u578b\u8003\u5bdf\u5355\u6297\u836f\u7269\u7684\u4f53\u5185PK\u884c\u4e3a <\/p>\n

12:00-13:00 Lunch \u5348\u9910<\/strong><\/p>\n

13:00-14:30 \u738b\u94b0\u73ba\uff0c<\/span><\/span><\/strong><\/p>\n

Case study-how to predict first in human PK profile and also evaluate the clinical dose
<\/p>\n

\u6848\u4f8b-\u9884\u6d4b\u9996\u6b21\u4eba\u4f53PK\u66f2\u7ebf\u53ca\u4e34\u5e8a\u7ed9\u836f\u5242\u91cf <\/p>\n

14:30-14:40 Tea break\u8336\u6b47<\/strong><\/p>\n

14:40-16:00 \u5468\u6d77\u82f1\uff0cSLP<\/strong><\/p>\n

The special population PK prediction based on PBPK modeling (including pediatric and diseased patient)<\/p>\n

\u57fa\u4e8ePBPK\u6a21\u578b\u9884\u6d4b\u513f\u7ae5\u53ca\u75c5\u4eba\u7684PK\u884c\u4e3a <\/p>\n

16:00-16:10 Tea break\u8336\u6b47<\/strong><\/p>\n

16:10-17:40 \u5468\u6d77\u82f1\uff0cSLP<\/strong><\/p>\n

Case study-Explain in vivo possible mechanism based on MembranePlus and GastroPlus PBPK model<\/p>\n

\u6848\u4f8b-\u7ed3\u5408\u4f53\u5916\u6e17\u900f\u6027\u6a21\u578b\u548cPBPK\u6a21\u578b\u63a2\u7d22\u5f71\u54cd\u836f\u7269\u4f53\u5185\u8fc7\u7a0b\u7684\u53ef\u80fd\u673a\u5236<\/p>\n

17:40-18:00 Panel discussion  \u5206\u7ec4\u8ba8\u8bba\u4e0e\u4e92\u52a8<\/strong><\/p>\n

18:00-20:30 Dinner party \u665a\u5bb4<\/strong><\/p>\n

5\u670817\u65e5\u5468\u4e94<\/strong><\/span><\/p>\n

8:30-9:30  \u8bb8\u53ef\uff0cSLP<\/strong><\/p>\n

Regulatory requirements and applications of DDI modeling, as well as the basic theory of GastroPlus DDI models<\/p>\n

DDI\u5efa\u6a21\u4e0e\u6a21\u62df\u7684\u6cd5\u89c4\u8981\u6c42\u4e0e\u5e94\u7528\uff0c\u4ee5\u53caGastroPlus DDI\u9884\u6d4b\u7684\u57fa\u672c\u539f\u7406<\/p>\n

9:30-9:40 Tea break \u8336\u6b47<\/strong><\/p>\n

9:40:10-11:30 \u8bb8\u53ef\uff0cSLP<\/strong><\/p>\n

Case study and operations of GastroPlus Steady-State and Dynamic simulation<\/p>\n

GastroPlus\u9759\u6001\u548c\u52a8\u6001DDI\u9884\u6d4b\u7684\u5e94\u7528\u6848\u4f8b\u53ca\u64cd\u4f5c<\/p>\n

11:30-12:30 Lunch \u5348\u9910<\/strong><\/p>\n

12:30-13:50 \u9648\u6d9b\uff0c<\/strong><\/p>\n

Case study-Raw data inputs, modeling and analysis, data supplement and assumption, result applications<\/p>\n

\u6848\u4f8b\u5206\u4eab-\u539f\u59cb\u6570\u636e\u8f93\u5165\u3001\u6a21\u578b\u642d\u5efa\u3001\u9884\u6d4b\u504f\u5dee\u5206\u6790\u3001\u6570\u636e\u8865\u5145\u3001\u5047\u8bbe\u4e0e\u8c03\u6574\u3001\u7ed3\u679c\u5e94\u7528\u7b49<\/p>\n

13:50-14:00 Tea break \u8336\u6b47<\/strong><\/p>\n

14:00-16:00 \u8bb8\u53ef\uff0cSLP<\/strong><\/p>\n

Metabolite tracking and enterohepatic circulation prediction by GastroPlus PBPK models<\/p>\n

\u901a\u8fc7GastroPlus\u6a21\u578b\u8fdb\u884c\u4ee3\u8c22\u4ea7\u7269\u8ffd\u8e2a\u3001\u809d\u80a0\u5faa\u73af\u7684\u9884\u6d4b <\/p>\n

16:00-16:30 Panel discussion \u7ec4\u95ee\u9898\u62a2\u7b54<\/strong><\/p>\n

16:30-17:00 Certificate & Awards \u9881\u53d1\u8bc1\u4e66\u4e0e\u9881\u5956<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n

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\u7f8e\u56fdSimulations Plus                   <\/p>\n

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 <\/strong>Course Instructors \u57f9\u8bad\u5e08<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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Haiying Zhou \u5468\u6d77\u82f1<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u9879\u76ee\u603b\u76d1\uff0c\u7f8e\u56fdSimulations Plus<\/strong><\/p>\n

10\u5e74\u7684\u5efa\u6a21\u4e0e\u6a21\u62df\u4ece\u4e1a\u7ecf\u9a8c\uff0c2009\u5e74\u52a0\u5165Simulations Plus\u516c\u53f8,\u4e13\u6ce8\u4e8e\u751f\u7406\u836f\u52a8\u5b66\u4e0e\u5438\u6536\u6a21\u578bGastroPlus\uff0c\u5236\u5242\u4f53\u5916\u5d29\u89e3\u4e0e\u6eb6\u51fa\u6a21\u62df\u8f6f\u4ef6DDDPlus\u7684\u5f00\u53d1\uff0c\u8fd1\u671f\u7684\u7814\u7a76\u65b9\u5411\u4e3a\u751f\u7269\u5927\u5206\u5b50\u7684\u751f\u7406\u836f\u52a8\u5b66\u6a21\u578b\uff08PBPK\uff09\u3002\u4e3a\u591a\u5bb6\u5236\u836f\u4f01\u4e1a\u3001\u7814\u7a76\u673a\u6784\u4f9b\u6280\u672f\u652f\u6301\u3002\u5468\u535a\u58eb2002\u5e74\u4e8e\u534e\u4e1c\u7406\u5de5\u5927\u5b66\u83b7\u5f97\u5b66\u58eb\u5b66\u4f4d\uff0c2009\u5e74\u83b7\u5f97\u7f8e\u56fdCase Western Reserve University\u751f\u7269\u533b\u5b66\u5de5\u7a0b\u4e13\u4e1a\u535a\u58eb\u5b66\u4f4d\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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Kay Szeto \u8bb8\u53ef<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u9ad8\u7ea7\u6280\u672f\u652f\u6301\uff0c\u7f8e\u56fdSimulations Plus<\/strong><\/p>\n

7\u5e74\u7684\u5efa\u6a21\u4e0e\u6a21\u62df\u4ece\u4e1a\u7ecf\u9a8c\uff0c2011\u5e74\u52a0\u5165Simulations Plus\u516c\u53f8\uff0c\u4e13\u6ce8\u4e8e\u4f53\u5916\u6e17\u900f\u548c\u836f\u4ee3\u52a8\u529b\u5b66\u7814\u7a76\uff0c\u8fd1\u5e74\u6765\u53c2\u4e0e\u591a\u9879\u6280\u672f\u5408\u4f5c\uff0c\u901a\u8fc7\u623f\u5ba4\u6216PBPK\u6a21\u578b\u8fdb\u884c\u7269\u79cd\u95f4\u5916\u63a8\uff08\u52a8\u7269\u5230\u4eba\uff09\uff0c\u9884\u6d4b\u53e3\u670d\u5236\u5242\u548c\u5176\u4ed6\u5242\u578b\u7684PK\u66f2\u7ebf\uff0c\u9884\u6d4b\u4e0d\u540c\u5242\u578b\u3001\u4e0d\u540c\u4eba\u7fa4\u7684\u836f\u7269\u76f8\u4e92\u4f5c\u7528DDI\u3002\u8bb8\u535a\u58eb\u5728\u7f8e\u56fd\u5317\u5361\u7f57\u6765\u7eb3\u5927\u5b66\u6559\u5802\u5c71\u5206\u6821\uff08UNC\uff09\u83b7\u5f97\u535a\u58eb\u5b66\u4f4d\uff0c\u4e4b\u540e\u5728UNC\u751f\u7269\u5de5\u7a0b\u53ca\u836f\u7406\u90e8\u4efb\u804c\uff0c\u7814\u7a76\u65b9\u5411\u4e3a\u91c7\u7528\u6570\u5b66\/\u7edf\u8ba1\u6a21\u578b\u6765\u89e3\u51b3\u751f\u7269\u5b66\u95ee\u9898\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n

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Tony Chen \u9648\u6d9b<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u6280\u672f\u603b\u76d1\uff0c\u4e0a\u6d77<\/strong><\/p>\n

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Kevin Xu \u8bb8\u5c24\u65b0<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u6280\u672f\u652f\u6301\uff0c\u4e0a\u6d77<\/strong><\/p>\n

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Eason Wang \u738b\u94b0\u73ba<\/strong><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n

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\u6280\u672f\u652f\u6301\uff0c\u4e0a\u6d77<\/strong><\/p>\n

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\"\u3010\u8bae\u7a0b\u30112019\u5236\u5242\u4e0e\u836f\u4ee3\u52a8\u529b\u5b66\u5efa\u6a21\u4e0e\u6a21\u62dfGastroPlus\u57f9\u8bad\u73ed\"<\/p>\n


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