一(yi)個新項(xiang)目開始之后，我們該如何確保RLD信息的(de)(de)(de)完整(zheng)和可(ke)靠性，使(shi)最終得(de)到的(de)(de)(de)數據能夠符合(he)ANDA申請的(de)(de)(de)要求呢(ni)？以(yi)(yi)下的(de)(de)(de)Checklist可(ke)以(yi)(yi)幫(bang)助我們來一(yi)項(xiang)一(yi)項(xiang)檢查：
| 1. Has the Reference Listed Drug (RLD) been chosen from the Orange Guide? |
| 參比制劑（RLD）是(shi)否選擇自橙皮書(shu)？ |
| 2. Has the RLD been purchased in all the proposed marketing sizes ? |
| RLD是否從(cong)目標市場采購？ |
| 3. Have different batch numbers (3 lot #’s) of the RLD been purchased? |
| 是否采購了3批不同的批號？ |
| 4. Confirm if the RLD is of recent manufacture (analyze new samples)? |
| RLD是否是近期生(sheng)產的(de)？ |
| 5. Conform that at least 10-20 samples of each RLD lot # and pack size are available for physical, chemical (assay and impurities), dissolution and stability testing? |
| 是否至少每個RLD批(pi)號都有10-20片樣品和包裝(zhuang)規格(ge)可以(yi)用來進行物(wu)理的、化學(xue)的（含量和雜質）、溶出和穩(wen)定性研究？ |
| 6. Confirm if the RLD has been placed on stability at 40o C for 3 months for evaluating potential degradation and impurity levels? |
| 是否RLD被放到40度3個月來考察降解和雜質水平？ |
| 7. Confirm if the impurity profile of the RLD has been evaluated? |
| RLD雜質譜是否被考(kao)察過？ |
| 8. Has reverse engineering of the RLD formula been performed? |
| RLD的(de)反向工程做過(guo)嗎？ |
| 9. Have the chosen inactive and maximum strength been cross-checked in the IIG? (for unique or unusual excipients)? |
| 選擇的輔料和最大用量有沒有超出IIG限度（針對特別的(de)或者不常用輔料）？ |
| 10. Are the in-actives qualitatively compatible with the RLD for oral use (composition and strength)? |
| 是否做過定性的原輔料相容性？ |
| 11 Have the RLD formula been reviewed in the International Drug Compendia (Italian, French, Swiss) for formula composition data? |
| RLD的(de)組(zu)成信息是(shi)否(fou)被國(guo)際藥典審閱過？ |
| 12. Has the FOI system been used to gather data on the Innovative drug? |
| FOI系統是否被用來收集(ji)創新藥的數(shu)據 |
| 13. Has a full analytical profile range been determined from analysis of the various batch lots of the RLD (at least 3 lots #’s for Assay; Content Uniformity; Impurities; Dissolution)? |
| 有完整的RLD批間差異的檢測范圍嗎？ |
| 14. Has the chosen RLD undergone stress testing to establish the level of its degradation products? |
| RLD是否使用強制降(jiang)解(jie)實驗來確定降(jiang)解(jie)產物的水平？ |
| 15. Has a multipoint dissolution of the several RLD batch lots been evaluated to assess the consistency of the RLD dissolution parameters? |
| 是否使用多批號RLD進行多(duo)點溶(rong)出實(shi)驗來評估RLD溶出參數(shu)的一致性？ |
