|
51
|
PK/PD |
於NDA與IND的生體可用率試驗之研發策略指導原則
|
2022-07-30 |
|
52
|
Quality |
再生醫療製劑中含經基因修飾細胞之化學製造管制研發策略指導原則
|
2021-11-22 |
|
53
|
Clinical |
診斷用造影劑之臨床研發策略指導原則
|
2021-11-22 |
|
54
|
Clinical |
愛滋病治療藥品之臨床研發策略指導原則
|
2021-11-22 |
|
55
|
Pharm/tox |
藥品生殖發育毒性檢測指導原則
|
2021-11-22 |
|
56
|
Product specific BE guideline |
Abiraterone acetate tablet_生體相等性試驗指導原則
|
2021-11-22 |
|
57
|
Product specific BE guideline |
Amlodipine + Atorvastatin tablet_生體相等性試驗指導原則
|
2021-11-22 |
|
58
|
Product specific BE guideline |
Azacitidine Lyophilized Powder for Injection_生體相等性試驗指導原則
|
2021-11-22 |
|
59
|
Product specific BE guideline |
Deferasirox Tablet for suspension_生體相等性試驗指導原則
|
2021-11-22 |
|
60
|
Product specific BE guideline |
Dutasteride capsule_生體相等性試驗指導原則
|
2021-11-22 |
