|
51
|
Pharm/tox |
小兒藥品之非臨床安全性測試指導原則
|
2025-09-24 |
|
52
|
Statistics |
臨床試驗調整設計之統計指導原則
|
2025-09-24 |
|
53
|
Clinical |
單臂試驗採用外部對照組之研發策略指導原則
|
2025-09-24 |
|
54
|
PK/PD |
腎功能不全病患的藥動學試驗指導原則(第二版)
|
2025-09-24 |
|
55
|
Clinical |
抗癌藥品臨床評估考量重點指導原則(第二版)
|
2025-09-24 |
|
56
|
Product specific BE guideline |
Lidocaine Patch-學名藥生體相等性試驗指導原則
|
2025-09-24 |
|
57
|
Product specific BE guideline |
Drospirenone/Ethinyl Estradiol Tablets-學名藥生體相等性試驗指導原則
|
2025-09-24 |
|
58
|
Product specific BE guideline |
Sorafenib Tosylate Tablets-學名藥生體相等性試驗指導原則
|
2025-09-24 |
|
59
|
Product specific BE guideline |
Sunitinib Hard Capsules-學名藥生體相等性試驗指導原則
|
2025-09-24 |
|
60
|
Product specific BE guideline |
Temozolomide Capsules-學名藥生體相等性試驗指導原則
|
2025-09-24 |
