Parent only. Chiral assay? [Regulatives / Guidelines]
@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...
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.
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
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