Ezetimibe BE [Regulatives / Guidelines]
Hi ElMaestro,
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.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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]
- 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 BEHelmut 2019-09-30 15:26