Parent only. Chiral assay? [Regulatives / Guidelines]
Hi ElMaestro & Elena777,
@Elena777: 1) according to the GL. Full stop.
@ElMaestro: Agree. Guideline = cookbook holy book nowadays.
Really? Happened to me only once in 2010 though the other way ’round.
Aye, capt’n!
Nothing to add to this one. In the meantime we have almost 70 APIs covered in product-specific guidances. In none a chiral assay is recommended.
@Elena777: 1) according to the GL. Full stop.
❝ my recent experience in EU is that they tend to ask for the parent, and only the parent, if this can be measured (and if systemically acting blah blah).
@ElMaestro: Agree. Guideline =
❝ There is also some regulatory wobble regarding enantiomers. Sometimes they ask for a chiral assay,……
Really? Happened to me only once in 2010 though the other way ’round.
❝ … and sometimes they don't and their choice seems not to always follow the formal criteria criteria stated in the guideline. I haven't cracked the code yet, but Hötzi has a good story about it from the horse's mouth.
❝ Hötzi, over to you...
Aye, capt’n!
Nothing to add to this one. In the meantime we have almost 70 APIs covered in product-specific guidances. In none a chiral assay is recommended.
—
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
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
Complete thread:
- Active metabolites: to measure or not to measure Elena777 2019-12-05 20:34 [Regulatives / Guidelines]
- Active metabolites: to measure or not to measure ElMaestro 2019-12-05 23:22
- Parent only. Chiral assay?Helmut 2019-12-06 00:26
- Active metabolites: to measure or not to measure ElMaestro 2019-12-05 23:22