Regulations of Bioavailability and Bioequivalence Studies Article 6
Reports should be written in the format required by the central competent health authority, and a complete report with any relevant study results should be submitted for assessment.Applicants should provide a written statement that test drugs are indeed the registered drugs. Applicants have the ultimate responsibility for the quality and integrity of study results.
中文原文 藥品生體可用率及生體相等性試驗作業準則第6條
試驗報告，應依中央衛生主管機關規定之方式撰寫，並檢附有關試驗之完整內容及試驗資料提交審核。
申請人應以書面聲明並確認執行試驗之藥品即為查驗登記之藥品。
試驗數據之品質與完整性之最終責任，應由申請人負責。
申請人應以書面聲明並確認執行試驗之藥品即為查驗登記之藥品。
試驗數據之品質與完整性之最終責任，應由申請人負責。