Co-dosed compounds stability effect [Regulatives / Guidelines]

posted by jchapdelaine – 2010-05-12 21:40 (5892 d 23:00 ago) – Posting: # 5335
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This deficiency was not addressed to my lab, therefore the only portion I have is what I posted. I do agree it looks very much like an FDA deficiency due to the font and layout.
This would be regarding BE studies, and we have been requested by some sponsors to evaluate this for inert molecules with no interconversion risk, such as ethinyl estradiol codosed with norgestrel. As a scientist I question the usefulness, while reducing the efficiency of the validation process. I understand evaluating stability in plasma having different types of anticoagulant, but this is going far beyond this.
However, I may be biased, therefore still looking for any good explanations.

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