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Dear Lakshmipathy,
» For test they are using old IPs and reference they are getting new IPs of same batch for the conduct of study. Our doubt is whether we have to have retention quantity for both old study and new study.
Then I will ask the same question again: what exactly do you not understand in section IV of the FDA guidance ? Did you read it carefully ? What is your opinion ?
» For test they are using old IPs and reference they are getting new IPs of same batch for the conduct of study. Our doubt is whether we have to have retention quantity for both old study and new study.
Then I will ask the same question again: what exactly do you not understand in section IV of the FDA guidance ? Did you read it carefully ? What is your opinion ?
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Shortage of retention quantity nlpati 2018-02-19 11:10
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Retention samples Ohlbe 2018-02-19 11:43
- Retention samples nlpati 2018-02-22 08:06
- ‘Add-on’ design? Helmut 2018-02-19 12:44
- ‘Add-on’ design? jag009 2018-02-21 20:24
- ‘Add-on’ design? nlpati 2018-02-22 08:12
- HomeworkOhlbe 2018-02-22 10:19
- Retention samples Ohlbe 2018-02-19 11:43
Ing. Helmut Schütz