お忙しい中、回答を頂き感謝します。
しかし、もう少し疑問が残っています。
１）確認試験について今までNIR,IR,TLCの3つの試験で実施していたとい認識でいいのか。NIRを実施しない理由ならびにアーカイブされた理由を教えてください。
２）試薬で登録している貴社の意見も十分理解ですますが、ベンズアルデヒドは出発物質として記載するとのPMDAの指示なので、その指示に従ってください。
Rating
53
Native
Translation / English
- Posted at 15 Jan 2020 at 11:11
Thank you for your reply despite your busy schedule.
However, I still have a few questions.
1) In regards to the confirmation examination, is it verified that these three examinations (NIR, IR and TLC) have been carried out up to now? If the NIR examination was not carried out, can you tell me the reason that was given and recorded?
2) I understand your company's opinion regarding the trial medicine that has been registered. However, as PMDA instructs that benzaldehyde be listed as a starting ingredient, so follow that instruction.
However, I still have a few questions.
1) In regards to the confirmation examination, is it verified that these three examinations (NIR, IR and TLC) have been carried out up to now? If the NIR examination was not carried out, can you tell me the reason that was given and recorded?
2) I understand your company's opinion regarding the trial medicine that has been registered. However, as PMDA instructs that benzaldehyde be listed as a starting ingredient, so follow that instruction.
Rating
50
Translation / English
- Posted at 15 Jan 2020 at 11:12
Thank you for your response while you are keeping busy.
However, I have some questions.
1) As for checking examinations, am I right to understand that we have carried out NIR, IR and TLC? Please tell me why NIR has not been carried out and archived.
2. I fully understand your opinion who registers the reagent, but if benzaldehyde is listed as starting material, as it is told by PMDA, please follow to the order.
However, I have some questions.
1) As for checking examinations, am I right to understand that we have carried out NIR, IR and TLC? Please tell me why NIR has not been carried out and archived.
2. I fully understand your opinion who registers the reagent, but if benzaldehyde is listed as starting material, as it is told by PMDA, please follow to the order.
Rating
50
Translation / English
- Posted at 15 Jan 2020 at 11:14
Thank you for your response while you are busy.
However, there is still some doubt.
1) Is it correct that the three tests NIR, IR, and TLC have been performed so far? Please tell us why NIR is not performed and why it was archived.
2) I understand your opinion registered as a reagent, but benzaldehyde is PMDA's instruction to be listed as a starting material, so please follow that instruction.
However, there is still some doubt.
1) Is it correct that the three tests NIR, IR, and TLC have been performed so far? Please tell us why NIR is not performed and why it was archived.
2) I understand your opinion registered as a reagent, but benzaldehyde is PMDA's instruction to be listed as a starting material, so please follow that instruction.
