|
31
|
Pharm/tox |
藥品致癌性試驗研發策略指導原則
|
2023-08-16 |
|
32
|
Quality |
用於治療嚴重衰弱或危及生命疾病之個人化反義寡核苷酸藥品的臨床試驗階段之化學製造管制指導原則_第一版
|
2023-07-24 |
|
33
|
Quality |
連續製程的品質考量之指導原則_第一版
|
2023-07-24 |
|
34
|
Statistics |
臨床試驗統計指導原則(第二版)
|
2023-03-15 |
|
35
|
Product specific BE guideline |
Lidocaine Patch-學名藥生體相等性試驗指導原則
|
2022-12-28 |
|
36
|
Product specific BE guideline |
Drospirenone/Ethinyl Estradiol Tablets-學名藥生體相等性試驗指導原則
|
2022-12-28 |
|
37
|
Product specific BE guideline |
Sorafenib Tosylate Tablets-學名藥生體相等性試驗指導原則
|
2022-12-28 |
|
38
|
Product specific BE guideline |
Sunitinib Hard Capsules-學名藥生體相等性試驗指導原則
|
2022-12-28 |
|
39
|
Product specific BE guideline |
Temozolomide Capsules-學名藥生體相等性試驗指導原則
|
2022-12-28 |
|
40
|
Product specific BE guideline |
Ticagrelor Tablets-學名藥生體相等性試驗指導原則
|
2022-12-28 |
