Dear Discussion group members,Back to the Top
Wish you all a very happy new year.
The query I have refers to formulating poorly water soluble NCE's for
preclinical safety and efficacy studies. Many of the NCE's being
sysnthesised at our centre are highly insoluble and I have to develop
formulation for Intravenous administration for various preclinical
safety reviewuations such as Acute, subacute toxicity study.
This usually require use of various solubilisers which may not be
approved for intravenous use by FDA. We do use vehicle control
(placebo formulation without drug) to eveluate effect of excepients.
My question is will US FDA object to this practice? Should we use
only approved excepients for formlating injections for animal
studies? We do carry out short term safety study of the formulation
used (without drug) to reviewuate the suitabiliry of the formula.
I would be grateful if any one can guide me through this.
The following message was posted to: PharmPKBack to the Top
If your intention is to submit then you had better use an approved
solvent. What is the point of not doing this?????
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