validation question-placebos or finished product

[martinamarie]

Hi, I was also wondering, if the placebo is going to be very different than the finished product, is is acceptable to spike the finished product with impurities for submission for a new drug application

Thanks Martina

[tom jupille]

My interpretation of "placebo" is that it should be the same as the finished product except for the presence of the API. The idea is to identify which peaks are *not* related to the API.

On those grounds, I would say "no".

[Alex Buske]

If the placebo is very different from the finished product, it is not a placebo in terms of chromatography. It might be used in clinical trials, but it is certainly not sufficient as a "validation placebo". How would you decide on the origin of peaks obtained? How could you check recovery?
Is it possible to obtain mixtures of the ingredients?
For recovery spiking finished product should work.

Alex