Parent only. Chiral assay? [Regulatives / Guidelines]
Hi ElMaestro & Elena777,
@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 = cookbook holy book nowadays.
» 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.
@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 🖖
![[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