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Dear Deepak,
Oh, you're absolutely right to perform a full validation, considering the changes made. My comment was rather that I personally would not have considered it necessary to have the metabolite in each and everyone of the new experiments performed.
Well, if you're unsure that the data you currently have will be sufficient, you should indeed start generating new long-term stability data. This way by the time the sponsor submits the data and gets the question from the FDA, you'll have your answer ready.
❝ We perform complete validation taking into account [...]
Oh, you're absolutely right to perform a full validation, considering the changes made. My comment was rather that I personally would not have considered it necessary to have the metabolite in each and everyone of the new experiments performed.
❝ We are also thinking to proceed for long term stability experiment for parent analyte with new method for analyte.
Well, if you're unsure that the data you currently have will be sufficient, you should indeed start generating new long-term stability data. This way by the time the sponsor submits the data and gets the question from the FDA, you'll have your answer ready.
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Long term stability deepakpangavhane 2019-01-09 13:54 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Long term stability VKB2207 2019-01-10 20:55
- Long term stability deepakpangavhane 2019-01-14 11:17
- Long term stability Ohlbe 2019-01-11 00:00
- Long term stability deepakpangavhane 2019-01-14 12:05
- Long term stability Ohlbe 2019-01-14 12:41
- Long term stability deepakpangavhane 2019-01-14 13:18
- Long term stabilityOhlbe 2019-01-14 14:04
- Long term stability deepakpangavhane 2019-01-14 13:18
- Long term stability Ohlbe 2019-01-14 12:41
- Long term stability deepakpangavhane 2019-01-14 12:05
- Long term stability VKB2207 2019-01-10 20:55
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