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RegisterEzetimibe BE [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2019-09-30 13:26 – Posting: # 20657
Views: 563
Hi ElMaestro,
» "The applicant should document that the enzymatic de-conjugation can be considered quantitative under assay conditions"
»
»
That would be a valid request. Has to be determined in method development & validation. No big deal, since β-glucuronidase is used for decades.
» "The applicant should document that the enzymatic de-conjugation can be considered quantitative under assay conditions"
»
»
That would be a valid request. Has to be determined in method development & validation. No big deal, since β-glucuronidase is used for decades.
—
Cheers,
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
Cheers,
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
Complete thread:
- Ezetimibe BE Mutasim 2019-09-23 14:40 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ezetimibe BE Helmut 2019-09-23 15:36
- Confusing guidance Helmut 2019-09-25 11:52
- Confusing guidance nobody 2019-09-25 13:36
- Ezetimibe final guidance Helmut 2019-09-28 12:11
- Ezetimibe final guidance Ohlbe 2019-09-30 11:03
- Ezetimibe final guidance Helmut 2019-09-30 15:33
- Ezetimibe final guidance Ohlbe 2019-09-30 11:03
- Ezetimibe BE ElMaestro 2019-09-30 13:12
- Ezetimibe BE Helmut 2019-09-30 15:26
Ing. Helmut Schütz