|
101
|
Product specific BE guideline |
Tenofovir Disoproxil Fumarate Tablet_生體相等性試驗指導原則
|
2025-09-24 |
|
102
|
Product specific BE guideline |
Ezetimibe+Simvastatin Tablets_生體相等性試驗指導原則_v2(新增QA)
|
2025-09-24 |
|
103
|
Product specific BE guideline |
Ezetimibe Tablets_生體相等性試驗指導原則_v2(新增QA)
|
2025-09-24 |
|
104
|
Statistics |
臨床試驗統計指導原則(第二版)
|
2025-09-24 |
|
105
|
Clinical |
鑑別及降低人體首次臨床試驗及早期臨床試驗之風險策略指引
|
2025-09-24 |
|
106
|
Clinical |
鑑別及降低人體首次臨床試驗及早期臨床試驗之風險策略指引(Q&A)
|
2025-09-24 |
|
107
|
Statistics |
確認性臨床試驗資料缺失之指導原則
|
2025-09-24 |
|
108
|
Quality |
抗體藥物複合體藥品於品質研發策略指導原則
|
2025-09-24 |
|
109
|
Pharm/tox |
抗體藥物複合體藥品非臨床藥毒理研發策略指導原則
|
2025-09-24 |
|
110
|
Pharm/tox |
核醫放射性藥品非臨床藥毒理研發策略指導原則
|
2025-09-24 |
