本站大部份資料在 2016 年後就未更新，若資料內無明確標示資料時間，請預設該資料為過時資料並斟酌使用，謝謝
| column | value |
|---|---|
| 類別 | 查驗登記類,藥品查驗登記審查準則,人用血漿製劑之查驗登記,生物性體外診斷試劑之查驗登記,疫苗類藥品之查驗登記,基因工程藥品之查驗登記,生物相似性藥品之查驗登記,過敏原生物藥品之查驗登記 |
| 法規性質 | 法規命令 |
| 法規名稱 | 「藥品查驗登記審查準則」附件五微脂粒（Liposome）及經皮吸收劑型學名藥查驗登記應檢附之技術性資料表 |
| 條文內容 | <p style="line-height: 20pt;"><span style="font-family: 新細明體,serif; color: #000000;">附件五</span><span style="color: #000000;"> </span><span style="font-family: 新細明體,serif; color: #000000;">微脂粒（</span><span style="color: #000000;">Liposome</span><span style="font-family: 新細明體,serif; color: #000000;">）</span><span style="font-family: 新細明體,serif; color: #000000; letter-spacing: -0.2pt;">及經皮吸收劑型學名藥查驗登記應檢附之技術性資料表</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;"> </span></p><table style="border-collapse: collapse; margin: auto auto auto 0.7pt;border: medium none;" border="1" cellspacing="0" cellpadding="0"> <tbody> <tr> <td valign="top" style="padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent;border: windowtext 1pt solid;"> <p> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="3"> <p class="null" style="text-align: center;"><span style="font-family: 新細明體;">起源、發現、經過、國外使用情形 </span></p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">物化</span> </p> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">性質</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="9"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">安</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">全</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">性</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">試</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">驗</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">報</span> <span style="font-size: 11pt; font-family: 新細明體,serif;">告</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="2"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">藥理</span> </p> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">作用</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="4"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">吸收、分佈、代謝、排泄</span><span style="font-size: 11pt;"><br /> </span><span style="font-size: 11pt; font-family: 新細明體,serif;">試驗報告</span><span style="font-size: 11pt;"><br /> </span><span style="font-size: 11pt; font-family: 新細明體,serif;">（動物</span><span style="font-size: 11pt;">/</span><span style="font-size: 11pt; font-family: 新細明體,serif;">人）</span> </p> </td> <td valign="top" style="border-top: windowtext 1pt solid; border-right: windowtext 1pt solid; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;" colspan="4"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">臨床試驗</span><span style="font-size: 11pt;"><br /> </span><span style="font-size: 11pt; font-family: 新細明體,serif;">報告</span> </p> </td> </tr> <tr> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <p> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">起源發現經過</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">國外使用情形</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">性質比較</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">構造式</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">物理化學性質</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">急性</span> </p> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">毒性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">亞急性毒性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">慢性毒性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">胚胎試驗</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">依賴性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">抗原性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">致突變性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">致癌性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">局部刺激性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">有效性證明</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">一般藥理</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">吸收</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">分佈</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">代謝</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">排泄</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">生體可用率</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">生體相等性</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">其他臨床試驗</span> </p> </td> <td valign="top" style="border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">醫藥期刊</span> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <h1 style="text-align: center; margin: auto 0cm; line-height: 19.8pt;"><span style="font-size: 10pt; font-family: 新細明體; font-weight: normal;">Liposome </span></h1> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <h1 style="text-align: center; margin: auto 0cm; line-height: 19.8pt;"><span style="font-size: 10pt; font-family: 新細明體; font-weight: normal;">學名藥(i) </span></h1> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">△</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <h1 style="text-align: center; margin: auto 0cm; line-height: 19.8pt;"><span style="font-size: 10pt; font-family: 新細明體; font-weight: normal;">學名藥(ii) </span></h1> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> <tr style="height: 19.8pt;"> <td style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">經皮吸收劑型</span> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> <td valign="top" style="height: 19.8pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"> </p> </td> </tr> <tr style="height: 7.2pt;"> <td style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; border-left: windowtext 1pt solid; padding-right: 1.4pt; background-color: transparent;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">學名藥</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">○</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">◎</span> </p> </td> <td valign="top" style="height: 7.2pt; border-right: windowtext 1pt solid; border-top-color: #f0f0f0; border-bottom: windowtext 1pt solid; padding-bottom: 0cm; padding-top: 0cm; padding-left: 1.4pt; padding-right: 1.4pt; background-color: transparent; border-left-color: #f0f0f0;"> <p style="text-align: center;"><span style="font-size: 11pt; font-family: 新細明體,serif;">╳</span> </p> </td> </tr> </tbody></table><p class="null" style="margin: auto 0cm auto 55pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">註：○表示須檢附該項目之資料。╳表示不須檢附該項目之資料。△表示視個案而定。 </span></p><p class="null" style="margin: auto 0cm auto 38.75pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">◎表示依下述方法擇一辦理：</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(1)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">生體相等性試驗。</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(2)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">生體可用率及臨床試驗。 </span></p><p class="null" style="margin: auto 0cm auto 38.75pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">學名藥</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(i)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">：主成分相同，但賦形劑成分及其比例不同之學名藥。 </span></p><p class="null" style="margin: auto 0cm auto 38.75pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">學名藥</span><span style="font-size: 13pt; font-family: verdana,sans-serif; color: #000000;">(ii)</span><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">：主成分、賦形劑成分及其比例皆相同之學名藥。 </span></p><p class="null" style="margin: auto 0cm auto 55pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">一、所申請藥品如有療效或安全之顧慮者，應依中央衛生主管機關要求，另檢送相關資料。 </span></p><p class="null" style="margin: auto 0cm auto 55pt; line-height: 20pt;"><span style="font-size: 13pt; font-family: 新細明體; color: #000000;">二、其他臨床試驗報告應依中央衛生主管機關公告之規定辦理。 </span></p> |
| 發佈日期 | 2013-12-03 |
| 附件檔案 | https://consumer.fda.gov.tw/DownLoadMethod/ashx/downloadFile.ashx?id=6096&type=0 |