Regulations of Bioavailability and Bioequivalence Studies Article 19
Bioavailability and bioequivalence studies and reports for special dosage forms (such as liposomes, transdermal, and inhalation) will be reviewed in a case-by-case basis by the central competent health authority depending on its quality and specification.
中文原文 藥品生體可用率及生體相等性試驗作業準則第19條
特殊劑型(如微脂粒、經皮吸收、吸入性等製劑)之生體相等性試驗及生體可用率試驗報告,由中央衛生主管機關視其品質、規格,依個案情形審核。