DISS厂商自评报告(空白).doc.docVIP

PAGE6 / NUMPAGES6 財團法人醫藥品查驗中心書面審查意見 溶離率曲線比對試驗技術資料廠商自評報告 Self-evaluation Report of Technical Document for Dissolution Study 建議廠商於送件前先行完成本自評報告，以利提升溶離率曲線比對試驗技術性資料完整性，進而加快審查時程。完成自評之廠商應提供自評報告之影本及電子檔。 表格資料若不適用者，可以註明 “不適用”；各表之欄位皆可適當增加，或以廠內表格代替。 若所檢送案件同時涉及生體相等性試驗與溶離率曲線比對試驗，請另填寫生體相等性試驗自評報告 (生體相等性試驗自評報告將於下一階段公佈)。 若同時檢送多劑量產品之申請案，請個別劑量單獨填寫一份自評報告。 Sponsor is encouraged to prepare the self-evaluation report in order to reveal/support the completeness of technical dossier of dissolution study, in hence to speed up the review process of regulatory agency.??If submitted, both hard copy and electronic copy of the report are required.? Additional columns and rows may be added to the tables as required.?Alternate table formats are also acceptable if the requested items are included. If the Submitted document involves both bioequivalence study and dissolution study, please fill the respective self-evaluation report.?Self-evaluation report for bioequivalence will be published early 2016. If application involves multiple strengths, please fill out the self-evaluation report separately.? 法規資訊表 Regulatory Information TFDA收文號 TFDA reference number 擬定商品 Brand Name (or proposed Name) 主成分 Active Ingredient(s) 劑量 Strength 申請廠商 Applicant 溶離率曲線比對試驗執行單位 Study execution unit /organization 本溶離比對試驗之目的 Purpose of dissolution study □申請查驗登記For ANDA □申請變更登記For post-approval change 請說明本次變更項目與原因___________________________ The rational and item of post-approval change(s) 受試藥品與對照藥品配方組成比較表 Comparison table for test drug and reference drug formula (請列出賦形劑、賦形劑功能、含量、變更前後或高低劑量之差異，並說明屬於主要或次要變更範圍) (Please compare the excipient, excipient function and excipient contents of two formula, and clarify the variations which may involve in major or minor changes) 受試藥品與對照藥品各項目比對表 Test drug and reference drug comparison tables (除前列配方組成比對外、請再提供原料藥來源比對、製劑批量、製程比對、規格比對及製造設備比對，各項比對表格不得以聲明書取代) (若能提供受試藥品與對照藥品批次製造紀錄更佳) (Comparative items should include source of raw material, batch size, manufacturing process, produ