一個(gè)新項(xiàng)目開始之后，我們?cè)撊绾未_保RLD信息的完整和可靠性，使最終得到的數(shù)據(jù)能夠符合ANDA申請(qǐng)的要求呢？以下的Checklist可以幫助我們來一項(xiàng)一項(xiàng)檢查：
| 1. Has the Reference Listed Drug (RLD) been chosen from the Orange Guide? |
| 參比制劑（RLD）是否選擇自橙皮書？ |
| 2. Has the RLD been purchased in all the proposed marketing sizes ? |
| RLD是否從目標(biāo)市場(chǎng)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(hào)？ |
| 4. Confirm if the RLD is of recent manufacture (analyze new samples)? |
| RLD是否是近期生產(chǎn)的？ |
| 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(gè)RLD批號(hào)都有10-20片樣品和包裝規(guī)格可以用來進(jìn)行物理的、化學(xué)的（含量和雜質(zhì)）、溶出和穩(wěn)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(gè)月來考察降解和雜質(zhì)水平？ |
| 7. Confirm if the impurity profile of the RLD has been evaluated? |
| RLD雜質(zhì)譜是否被考察過？ |
| 8. Has reverse engineering of the RLD formula been performed? |
| RLD的反向工程做過嗎？ |
| 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(duì)特別的或者不常用輔料）？ |
| 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的組成信息是否被國際藥典審閱過？ |
| 12. Has the FOI system been used to gather data on the Innovative drug? |
| FOI系統(tǒng)是否被用來收集創(chuàng)新藥的數(shù)據(jù) |
| 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(cè)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(qiáng)制降解實(shí)驗(yàn)來確定降解產(chǎn)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(hào)RLD進(jìn)行多點(diǎn)溶出實(shí)驗(yàn)來評(píng)估RLD溶出參數(shù)的一致性？ |
