106-1
2.下列那一項資料在新藥申請（NDA）是必備的，但在簡易新藥申請（ANDA）不需提供？
A.藥品的化學製造
B.生體可用率／生體相等性
C.藥品之品管
D.臨床試驗
學名藥的申請不需要經過臨床前及臨床試驗，因此為簡易(abbreviated)新藥申請。
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
資料來源：FDA-abbreviated new drug application (ANDA)
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