|
71
|
Multidisciplinary |
食藥署公布之各類新藥查驗登記審查重點-106.03.02
|
2021-10-08 |
|
72
|
Clinical |
Trastuzumab生物相似性藥品之臨床研發策略指導原則
|
2020-11-25 |
|
73
|
Statistics |
臨床試驗之估計目標(estimand)與敏感度分析(sensitivity analysis)
|
2020-11-25 |
|
74
|
PK/PD |
小兒族群的藥動學試驗指導原則
|
2020-11-25 |
|
75
|
Product specific BE guideline |
Clopidogrel Bisulfate Tablets_生體相等性試驗指導原則
|
2020-07-21 |
|
76
|
Product specific BE guideline |
Dapoxetine FCT_生體相等性試驗指導原則
|
2020-07-21 |
|
77
|
Product specific BE guideline |
Erlotinib_生體相等性試驗指導原則
|
2020-07-21 |
|
78
|
Product specific BE guideline |
Memantine HCl tablet_生體相等性試驗指導原則
|
2020-07-21 |
|
79
|
Product specific BE guideline |
Paliperidone ER Tablet_生體相等性試驗指導原則
|
2020-07-21 |
|
80
|
Product specific BE guideline |
Pregabalin capsule_生體相等性試驗指導原則
|
2020-07-21 |
