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RegisterRetention requirements for comparator [Regulatives / Guidelines]
Dear Gunasakaran
Thank you.
Actually the question is general.
Thank you for the links, actually I was missing the proper section of Annex 13.
Kind regards
Dear Gunasakaran
Sorry, puzzled again.
I understand the requirements for the product in test (either reference or retention) but if I use in a trial a comparator product from the market not modified (eg. not repacked), is this included in the definition or not?
thank you
Edit: Merged a later post. No need to open a new one. [Helmut]
Thank you.
Actually the question is general.
Thank you for the links, actually I was missing the proper section of Annex 13.
Kind regards
Dear Gunasakaran
Sorry, puzzled again.
I understand the requirements for the product in test (either reference or retention) but if I use in a trial a comparator product from the market not modified (eg. not repacked), is this included in the definition or not?
thank you
Edit: Merged a later post. No need to open a new one. [Helmut]
—
AUClast
AUClast
Complete thread:
- Retention requirements for comparator AUClast 2012-11-08 18:46
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Retention requirements for comparator drgunasakaran1 2012-11-09 02:31
- Retention requirements for comparatorAUClast 2012-11-09 11:24
- Retention requirements for comparator drgunasakaran1 2012-11-09 02:31
Ing. Helmut Schütz